Palindrome 8888145044CRecalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10884521056312), received between Feb 14, 2022 and Feb 5, 2025 — classified as 1 death, 37 malfunctions.

The most frequently reported specific device problem is “Break” (36 reports).

1 FDA recall record name this device's identifier, 1 still open.

64 other recalls cover devices cleared under the same FDA submission (K112477); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jun 8, 2022Class IOpen, Classified

   There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

   Z-1317-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, AN ALERT FROM THE PHARMACY FOR INDOOR USE ON OVERCONSUMPTION OF FIBRINOLYTIC (ACTILYSIS) SINCE THE BEGINNING OF JANUARY. IN SERVICE CALL, IT WAS STATED THAT PRESENCE OF AN INCREASE IN BLOCKED CATHETERS. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. THE INSERTION SITE WAS TREATED WITH PRIOR TO PRODUCT PLACEMENT. IT WAS ALSO STATED THAT THERE WERE PATIENTS SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT SUCH AS DELAY IN PATIENT CARE OR EXTENSION OF HOSPITALIZATION, DISRUPTION OF THE OPERATION OF THE SERVICE OR INTER-SERVICE RELATIONS. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 21314350 ↗
• DeathNov 4, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING TREATMENT, THE LUER ADAPTER BROKE/CRACKED WHILE USING TEGO. THE PATIENT DIED.

  Patient problems: Insufficient Information

  MAUDE report 15735761 ↗
• MalfunctionNov 4, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, THE LUER ADAPTER BROKE/CRACKED WHILE USING TEGO. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. ALCOHOL AS PER IFU (INSTRUCTION FOR USE) WAS THE CLEANING AGENT TYPICALLY UTILIZED TO CLEAN THE DEVICE AND THE ADAPTER ITSELF. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. HAND WAS UTILIZED TO TIGHTEN THE ADAPTERS. TEGO WAS BEING UTILIZED WITH THE DEVICE. IT WAS SAID THAT THERE WERE BLOOD LEAK/LOSS FROM THE CRACK ON THE LUER ADAPTER BUT DROPS ONLY. THERE WAS NO BLOOD TRANSFUSION REQUIRED. THE PATIENT HAD NO MEDICAL INTERVENTION/TREATMENT DUE TO THE EVENT. THE CATHETER WAS REPLACED. TREATMENT WAS STILL COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15730617 ↗
• MalfunctionNov 4, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, THE LUER ADAPTER BROKE/CRACKED WHILE USING TEGO. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. ALCOHOL AS PER IFU (INSTRUCTION FOR USE) WAS THE CLEANING AGENT TYPICALLY UTILIZED TO CLEAN THE DEVICE AND THE ADAPTER ITSELF. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. HAND WAS UTILIZED TO TIGHTEN THE ADAPTERS. TEGO WAS BEING UTILIZED WITH THE DEVICE. IT WAS SAID THAT THERE WERE BLOOD LEAK/LOSS FROM THE CRACK ON THE LUER ADAPTER BUT DROPS ONLY. THERE WAS NO BLOOD TRANSFUSION REQUIRED. THE PATIENT HAD NO MEDICAL INTERVENTION/TREATMENT DUE TO THE EVENT. THE CATHETER WAS REPAIRED. TREATMENT WAS STILL COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15730609 ↗
• MalfunctionNov 4, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, THE LUER ADAPTER BROKE/CRACKED WHILE USING TEGO. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. ALCOHOL AS PER IFU (INSTRUCTION FOR USE) WAS THE CLEANING AGENT TYPICALLY UTILIZED TO CLEAN THE DEVICE AND THE ADAPTER ITSELF. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. HAND WAS UTILIZED TO TIGHTEN THE ADAPTERS. TEGO WAS BEING UTILIZED WITH THE DEVICE. IT WAS SAID THAT THERE WERE BLOOD LEAK/LOSS FROM THE CRACK ON THE LUER ADAPTER BUT DROPS ONLY. THERE WAS NO BLOOD TRANSFUSION REQUIRED. THE PATIENT HAD NO MEDICAL INTERVENTION/TREATMENT DUE TO THE EVENT. THE CATHETER WAS REPAIRED. TREATMENT WAS STILL COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15729589 ↗
• MalfunctionNov 4, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, THE LUER ADAPTER BROKE/CRACKED WHILE USING TEGO. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. ALCOHOL AS PER IFU (INSTRUCTION FOR USE) WAS THE CLEANING AGENT TYPICALLY UTILIZED TO CLEAN THE DEVICE AND THE ADAPTER ITSELF. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. HAND WAS UTILIZED TO TIGHTEN THE ADAPTERS. TEGO WAS BEING UTILIZED WITH THE DEVICE. IT WAS SAID THAT THERE WERE BLOOD LEAK/LOSS FROM THE CRACK ON THE LUER ADAPTER BUT DROPS ONLY. THERE WAS NO BLOOD TRANSFUSION REQUIRED. THE PATIENT HAD NO MEDICAL INTERVENTION/TREATMENT DUE TO THE EVENT. THE CATHETER WAS REPAIRED. TREATMENT WAS STILL COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15728927 ↗
• MalfunctionNov 4, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, THE LUER ADAPTER BROKE/CRACKED WHILE USING TEGO. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. ALCOHOL AS PER IFU (INSTRUCTION FOR USE) WAS THE CLEANING AGENT TYPICALLY UTILIZED TO CLEAN THE DEVICE AND THE ADAPTER ITSELF. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. HAND WAS UTILIZED TO TIGHTEN THE ADAPTERS. TEGO WAS BEING UTILIZED WITH THE DEVICE. IT WAS SAID THAT THERE WERE BLOOD LEAK/LOSS FROM THE CRACK ON THE LUER ADAPTER BUT DROPS ONLY. THERE WAS NO BLOOD TRANSFUSION REQUIRED. THE PATIENT HAD NO MEDICAL INTERVENTION/TREATMENT DUE TO THE EVENT. THE CATHETER WAS REPAIRED. TREATMENT WAS STILL ABLE TO BE COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15728680 ↗
• MalfunctionNov 4, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, THE LUER ADAPTER BROKE/CRACKED WHILE USING TEGO. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. ALCOHOL AS PER IFU (INSTRUCTION FOR USE) WAS THE CLEANING AGENT TYPICALLY UTILIZED TO CLEAN THE DEVICE AND THE ADAPTER ITSELF. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. HAND WAS UTILIZED TO TIGHTEN THE ADAPTERS. TEGO WAS BEING UTILIZED WITH THE DEVICE. IT WAS SAID THAT THERE WERE BLOOD LEAK/LOSS FROM THE CRACK ON THE LUER ADAPTER BUT DROPS ONLY. THERE WAS NO BLOOD TRANSFUSION REQUIRED. THE PATIENT HAD NO MEDICAL INTERVENTION/TREATMENT DUE TO THE EVENT. THE CATHETER WAS REPLACED. TREATMENT WAS STILL ABLE TO BE COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15728436 ↗
• MalfunctionNov 4, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, THE LUER ADAPTER BROKE/CRACKED WHILE USING TEGO. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. ALCOHOL AS PER IFU (INSTRUCTION FOR USE) WAS THE CLEANING AGENT TYPICALLY UTILIZED TO CLEAN THE DEVICE AND THE ADAPTER ITSELF. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. HAND WAS UTILIZED TO TIGHTEN THE ADAPTERS. TEGO WAS BEING UTILIZED WITH THE DEVICE. IT WAS SAID THAT THERE WERE BLOOD LEAK/LOSS FROM THE CRACK ON THE LUER ADAPTER BUT DROPS ONLY. THERE WAS NO BLOOD TRANSFUSION REQUIRED. THE PATIENT HAD NO MEDICAL INTERVENTION/TREATMENT DUE TO THE EVENT. THE CATHETER WAS REPAIRED. TREATMENT WAS STILL COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15727627 ↗
• MalfunctionNov 4, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, THE LUER ADAPTER BROKE/CRACKED WHILE USING TEGO. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. ALCOHOL AS PER IFU (INSTRUCTION FOR USE) WAS THE CLEANING AGENT TYPICALLY UTILIZED TO CLEAN THE DEVICE AND THE ADAPTER ITSELF. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. HAND WAS UTILIZED TO TIGHTEN THE ADAPTERS. TEGO WAS BEING UTILIZED WITH THE DEVICE. IT WAS SAID THAT THERE WERE BLOOD LEAK/LOSS FROM THE CRACK ON THE LUER ADAPTER BUT DROPS ONLY. THERE WAS NO BLOOD TRANSFUSION REQUIRED. THE PATIENT HAD NO MEDICAL INTERVENTION/TREATMENT DUE TO THE EVENT. THE CATHETER WAS REPAIRED. TREATMENT WAS STILL COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15726854 ↗
• MalfunctionNov 4, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, THE LUER ADAPTER BROKE/CRACKED WHILE USING TEGO. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. ALCOHOL AS PER IFU (INSTRUCTION FOR USE) WAS THE CLEANING AGENT TYPICALLY UTILIZED TO CLEAN THE DEVICE AND THE ADAPTER ITSELF. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. HAND WAS UTILIZED TO TIGHTEN THE ADAPTERS. TEGO WAS BEING UTILIZED WITH THE DEVICE. IT WAS SAID THAT THERE WERE BLOOD LEAK/LOSS FROM THE CRACK ON THE LUER ADAPTER BUT DROPS ONLY. THERE WAS NO BLOOD TRANSFUSION REQUIRED. THE PATIENT HAD NO MEDICAL INTERVENTION/TREATMENT DUE TO THE EVENT. THE CATHETER WAS REPAIRED. TREATMENT WAS STILL COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15726268 ↗
• MalfunctionNov 4, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, THE LUER ADAPTER BROKE/CRACKED WHILE USING TEGO. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. ALCOHOL AS PER IFU (INSTRUCTION FOR USE) WAS THE CLEANING AGENT TYPICALLY UTILIZED TO CLEAN THE DEVICE AND THE ADAPTER ITSELF. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. HAND WAS UTILIZED TO TIGHTEN THE ADAPTERS. TEGO WAS BEING UTILIZED WITH THE DEVICE. IT WAS SAID THAT THERE WERE BLOOD LEAK/LOSS FROM THE CRACK ON THE LUER ADAPTER BUT DROPS ONLY. THERE WAS NO BLOOD TRANSFUSION REQUIRED. THE PATIENT HAD NO MEDICAL INTERVENTION/TREATMENT DUE TO THE EVENT. THE CATHETER WAS REPAIRED. TREATMENT WAS STILL COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15725928 ↗
• MalfunctionNov 4, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, THE LUER ADAPTER BROKE/CRACKED WHILE USING TEGO. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. ALCOHOL AS PER IFU (INSTRUCTION FOR USE) WAS THE CLEANING AGENT TYPICALLY UTILIZED TO CLEAN THE DEVICE AND THE ADAPTER ITSELF. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. HAND WAS UTILIZED TO TIGHTEN THE ADAPTERS. TEGO WAS BEING UTILIZED WITH THE DEVICE. IT WAS SAID THAT THERE WERE BLOOD LEAK/LOSS FROM THE CRACK ON THE LUER ADAPTER BUT DROPS ONLY. THERE WAS NO BLOOD TRANSFUSION REQUIRED. THE PATIENT HAD NO MEDICAL INTERVENTION/TREATMENT DUE TO THE EVENT. THE CATHETER WAS REPLACED. THE DIALYSIS TREATMENT WAS STOPPED BUT THEY WERE STILL ABLE TO COMPLETE IT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15725883 ↗
• MalfunctionNov 4, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, THE LUER ADAPTER BROKE/CRACKED WHILE USING TEGO. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. ALCOHOL AS PER IFU (INSTRUCTION FOR USE) WAS THE CLEANING AGENT TYPICALLY UTILIZED TO CLEAN THE DEVICE AND THE ADAPTER ITSELF. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. HAND WAS UTILIZED TO TIGHTEN THE ADAPTERS. TEGO WAS BEING UTILIZED WITH THE DEVICE. IT WAS SAID THAT THERE WERE BLOOD LEAK/LOSS FROM THE CRACK ON THE LUER ADAPTER BUT DROPS ONLY. THERE WAS NO BLOOD TRANSFUSION REQUIRED. THE PATIENT HAD NO MEDICAL INTERVENTION/TREATMENT DUE TO THE EVENT. THE CATHETER WAS REPLACED WITH ANOTHER BRAND. TREATMENT WAS STILL COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15725210 ↗
• MalfunctionNov 4, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, THE LUER ADAPTER BROKE/CRACKED WHILE USING TEGO. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. ALCOHOL AS PER IFU (INSTRUCTION FOR USE) WAS THE CLEANING AGENT TYPICALLY UTILIZED TO CLEAN THE DEVICE AND THE ADAPTER ITSELF. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. HAND WAS UTILIZED TO TIGHTEN THE ADAPTERS. TEGO WAS BEING UTILIZED WITH THE DEVICE. IT WAS SAID THAT THERE WERE BLOOD LEAK/LOSS FROM THE CRACK ON THE LUER ADAPTER BUT DROPS ONLY. THERE WAS NO BLOOD TRANSFUSION REQUIRED. THE PATIENT HAD NO MEDICAL INTERVENTION/TREATMENT DUE TO THE EVENT. THE CATHETER WAS REPAIRED. TREATMENT WAS STILL COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15725105 ↗
• MalfunctionNov 4, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, THE LUER ADAPTER BROKE/CRACKED WHILE USING TEGO. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. ALCOHOL AS PER IFU (INSTRUCTION FOR USE) WAS THE CLEANING AGENT TYPICALLY UTILIZED TO CLEAN THE DEVICE AND THE ADAPTER ITSELF. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. HAND WAS UTILIZED TO TIGHTEN THE ADAPTERS. TEGO WAS BEING UTILIZED WITH THE DEVICE. IT WAS SAID THAT THERE WERE BLOOD LEAK/LOSS FROM THE CRACK ON THE LUER ADAPTER BUT DROPS ONLY. THERE WAS NO BLOOD TRANSFUSION REQUIRED. THE PATIENT HAD NO MEDICAL INTERVENTION/TREATMENT DUE TO THE EVENT. THE CATHETER WAS REPAIRED. TREATMENT WAS STILL COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15724438 ↗
• MalfunctionNov 3, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, THE LUER ADAPTER BROKE/CRACKED WHILE USING TEGO. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. ALCOHOL AS PER IFU (INSTRUCTION FOR USE) WAS THE CLEANING AGENT TYPICALLY UTILIZED TO CLEAN THE DEVICE AND THE ADAPTER ITSELF. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. HAND WAS UTILIZED TO TIGHTEN THE ADAPTERS. TEGO WAS BEING UTILIZED WITH THE DEVICE. IT WAS SAID THAT THERE WERE BLOOD LEAK/LOSS FROM THE CRACK ON THE LUER ADAPTER BUT DROPS ONLY. THERE WAS NO BLOOD TRANSFUSION REQUIRED. THE PATIENT HAD NO MEDICAL INTERVENTION/TREATMENT DUE TO THE EVENT. THE CATHETER WAS REPAIRED. TREATMENT WAS STILL COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15722463 ↗
• MalfunctionNov 3, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, THE LUER ADAPTER BROKE/CRACKED WHILE USING EGO. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. ALCOHOL AS PER IFU (INSTRUCTION FOR USE) WAS THE CLEANING AGENT TYPICALLY UTILIZED TO CLEAN THE DEVICE AND THE ADAPTER ITSELF. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. HAND WAS UTILIZED TO TIGHTEN THE ADAPTERS. EGO WAS BEING UTILIZED WITH THE DEVICE. IT WAS SAID THAT THERE WERE BLOOD LEAK/LOSS FROM THE CRACK ON THE LUER ADAPTER BUT DROPS ONLY. THERE WAS NO BLOOD TRANSFUSION REQUIRED. THE PATIENT HAD NO MEDICAL INTERVENTION/TREATMENT DUE TO THE EVENT. TREATMENT WAS STILL ABLE TO BE COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15722273 ↗
• MalfunctionNov 3, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, THE LUER ADAPTER BROKE/CRACKED WHILE USING TEGO. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. ALCOHOL AS PER IFU (INSTRUCTION FOR USE) WAS THE CLEANING AGENT TYPICALLY UTILIZED TO CLEAN THE DEVICE AND THE ADAPTER ITSELF. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. HAND WAS UTILIZED TO TIGHTEN THE ADAPTERS. TEGO WAS BEING UTILIZED WITH THE DEVICE. IT WAS SAID THAT THERE WERE BLOOD LEAK/LOSS FROM THE CRACK ON THE LUER ADAPTER BUT DROPS ONLY. THERE WAS NO BLOOD TRANSFUSION REQUIRED. THE PATIENT HAD NO MEDICAL INTERVENTION/TREATMENT DUE TO THE EVENT. THE CATHETER WAS REPAIRED. TREATMENT WAS STILL COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15722067 ↗
• MalfunctionNov 2, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING DIALYSIS, THE RED (ARTERIAL) LUER ADAPTERS OF THE LUMEN WAS COMPLETELY BROKEN (CRACK) AND HAD A LEAKAGE WHILE USING TEGO. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. CLEANING OF THE DEVICE AS WELL AS ON THE ADAPTERS ITSELF WAS DONE WITH ALCOHOL AS PER IFU (INSTRUCTION FOR USE). THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE/ADAPTER AND HAND WAS USED INSTEAD. IT WAS SAID THAT THERE WERE BLOOD LEAK/LOSS FROM THE CRACK ON THE LUER ADAPTER BUT DROPS ONLY. THERE WAS NO BLOOD TRANSFUSION REQUIRED. THE PATIENT HAD NO MEDICAL INTERVENTION/TREATMENT DUE TO THE EVENT. TREATMENT WAS COMPLETED. IT WAS SAID THAT THE PRODUCT WAS REPAIRED BY A REPAIR KIT BUT THEY ALSO EXPERIENCED ISSUES (CRACKS) WITH THE REPAIR KIT. THE CATHETER REMAINED IN PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15716731 ↗
• MalfunctionNov 2, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, THE LUER ADAPTER BROKE/CRACKED WHILE USING TEGO. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. ALCOHOL AS PER IFU (INSTRUCTION FOR USE) WAS THE CLEANING AGENT TYPICALLY UTILIZED TO CLEAN THE DEVICE AND THE ADAPTER ITSELF. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. HAND WAS UTILIZED TO TIGHTEN THE ADAPTERS. TEGO WAS BEING UTILIZED WITH THE DEVICE. IT WAS SAID THAT THERE WERE BLOOD LEAK/LOSS FROM THE CRACK ON THE LUER ADAPTER BUT DROPS ONLY. THERE WAS NO BLOOD TRANSFUSION REQUIRED. THE PATIENT HAD NO MEDICAL INTERVENTION/TREATMENT DUE TO THE EVENT. THE CATHETER WAS REPAIRED. TREATMENT WAS STILL COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15715237 ↗
• MalfunctionNov 2, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, THE LUER ADAPTER BROKE/CRACKED WHILE USING TEGO. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. ALCOHOL AS PER IFU (INSTRUCTION FOR USE) WAS THE CLEANING AGENT TYPICALLY UTILIZED TO CLEAN THE DEVICE AND THE ADAPTER ITSELF. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. HAND WAS UTILIZED TO TIGHTEN THE ADAPTERS. TEGO WAS BEING UTILIZED WITH THE DEVICE. IT WAS SAID THAT THERE WERE BLOOD LEAK/LOSS FROM THE CRACK ON THE LUER ADAPTER BUT DROPS ONLY. THERE WAS NO BLOOD TRANSFUSION REQUIRED. THE PATIENT HAD NO MEDICAL INTERVENTION/TREATMENT DUE TO THE EVENT. THE CATHETER WAS REPLACED. TREATMENT WAS STILL COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15713991 ↗
• MalfunctionNov 2, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, THE LUER ADAPTER BROKE/CRACKED WHILE USING TEGO. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. ALCOHOL AS PER IFU (INSTRUCTION FOR USE) WAS THE CLEANING AGENT TYPICALLY UTILIZED TO CLEAN THE DEVICE AND THE ADAPTER ITSELF. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. HAND WAS UTILIZED TO TIGHTEN THE ADAPTERS. TEGO WAS BEING UTILIZED WITH THE DEVICE. IT WAS SAID THAT THERE WERE BLOOD LEAK/LOSS FROM THE CRACK ON THE LUER ADAPTER BUT DROPS ONLY. THERE WAS NO BLOOD TRANSFUSION REQUIRED. THE PATIENT HAD NO MEDICAL INTERVENTION/TREATMENT DUE TO THE EVENT. TREATMENT WAS STILL COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15713982 ↗
• MalfunctionNov 2, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, THE LUER ADAPTER BROKE/CRACKED WHILE USING TEGO. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. ALCOHOL AS PER IFU (INSTRUCTION FOR USE) WAS THE CLEANING AGENT TYPICALLY UTILIZED TO CLEAN THE DEVICE AND THE ADAPTER ITSELF. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. HAND WAS UTILIZED TO TIGHTEN THE ADAPTERS. TEGO WAS BEING UTILIZED WITH THE DEVICE. IT WAS SAID THAT THERE WERE BLOOD LEAK/LOSS FROM THE CRACK ON THE LUER ADAPTER BUT DROPS ONLY. THERE WAS NO BLOOD TRANSFUSION REQUIRED. THE PATIENT HAD NO MEDICAL INTERVENTION/TREATMENT DUE TO THE EVENT. THE CATHETER WAS REPAIRED. TREATMENT WAS STILL COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15713971 ↗
• MalfunctionNov 2, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, THE LUER ADAPTER BROKE/CRACKED WHILE USING TEGO. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. ALCOHOL AS PER IFU (INSTRUCTION FOR USE) WAS THE CLEANING AGENT TYPICALLY UTILIZED TO CLEAN THE DEVICE AND THE ADAPTER ITSELF. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. HAND WAS UTILIZED TO TIGHTEN THE ADAPTERS. TEGO WAS BEING UTILIZED WITH THE DEVICE. IT WAS SAID THAT THERE WERE BLOOD LEAK/LOSS FROM THE CRACK ON THE LUER ADAPTER BUT DROPS ONLY. THERE WAS NO BLOOD TRANSFUSION REQUIRED. THE PATIENT HAD NO MEDICAL INTERVENTION/TREATMENT DUE TO THE EVENT. THE CATHETER WAS REPAIRED. TREATMENT WAS STILL COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15713958 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112477. One submission often covers many models, so check the product and lot details in each record.

• Z-1319-2022 · Jun 8, 2022 · Open, Classified
  Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
• Z-1318-2022 · Jun 8, 2022 · Open, Classified
  Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
• Z-1878-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066P
• Z-1871-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063CP
• Z-1900-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145049P
• Z-1884-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119368P
• Z-1872-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064P
• Z-1906-2015 · Apr 23, 2015 · Terminated
  Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128459
• Z-1892-2015 · Apr 23, 2015 · Terminated
  Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145049
• Z1855-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 23 cm Item Code: 8888223408
• Z-1862-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code:8888145064
• Z-1873-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064CP
• Z-1905-2015 · Apr 23, 2015 · Terminated
  Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123409
• Z-1908-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119369P
• Z-1888-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133508P

…and 49 more.