NA 8888200001Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10884521056282), received between Feb 21, 2018 and Sep 15, 2025 — classified as 1 death, 17 malfunctions.

The most frequently reported specific device problem is “Break” (17 reports).

1 other recall cover devices cleared under the same FDA submission (K092797); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2025Break; Break

  ACCORDING TO THE REPORTER, THE CATHETER WAS IMPLANTED ON (B)(6)2025, AND ON THE DAY OF THE EVENT, THE CRACK WAS OBSERVED. THREAD BREAKAGE OF THE ARTERIAL BRANCH REQUIRING THE REPLACEMENT OF THE ARTERIAL END. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 23051909 ↗
• DeathMay 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON THE DAY OF THE EVENT, THE PATIENT WAS IN THE ER (EMERGENCY ROOM) FOR EMESIS, ELEVATED WBC (WHITE BLOOD CELLS), AND HGB (HEMOGLOBIN) 6.4. BASED ON LAB WORK, DIALYSIS WAS NEEDED, AND THE PATIENT WAS TAKEN TO THE DIALYSIS UNIT. THE BLOOD FLOW FOR DIALYSIS WAS 400, WHICH WAS CONSISTENT WITH NORMAL TREATMENT PRESCRIPTION. ACCORDING TO THEIR RECORDS, THE BLOODLINE CONNECTION WAS SECURE AND HAD A CONNECTOR ON IT THAT SECURED THE BLOODLINES TO THE CATHETER (WAS REFERRED TO AS A SECURE LOCK). SHORTLY AFTER THE START OF LONG-TERM DIALYSIS, THE DIALYSIS MACHINE ALARMED. THE NURSE RESPONDED TO THE MACHINE ALARM, AND IT WAS FOUND THAT THE VENOUS PORT/HUB HAD DISCONNECTED, WHICH LED TO SIGNIFICANT BLOOD LOSS. THE RAPID RESPONSE TEAM WAS ENGAGED. THE MACHINE WAS MAINTAINED BY THE 3RD PARTIES BIOMED. FOR THE HOSPITAL, IT STATED THE MACHINE WAS NOT A CONCERN; IT DID WHAT IT WAS SUPPOSED TO AND ALARMED ACCORDING TO THE 3RD PARTY. THE MACHINES WERE MAINTAINED BY A 3RD PARTY, AS THEY WERE THE 3RD PARTY¿S EQUIPMENT. THE HOSPITAL DID NOT HAVE ACCESS TO VERIFY THE MACHINE ALARMED. IT WAS CONFIRMED THAT THE CATHETER HAD PREVIOUSLY UNDERGONE A REPAIR ON (B)(6) 2024. THE LOCUM

  Patient problems: Asystole; Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Ventricular Fibrillation

  MAUDE report 22097479 ↗
• 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 15728389 ↗
• 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 15726304 ↗
• 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 15723306 ↗
• 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 15722996 ↗
• 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 15717886 ↗
• 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 15717696 ↗
• 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 15717616 ↗
• 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 15717459 ↗
• 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 15715211 ↗
• 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 15714897 ↗
• 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 15714885 ↗
• 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 15714080 ↗
• 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 15714064 ↗
• MalfunctionNov 1, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING DIALYSIS, THE RED (ARTERIAL) LUER ADAPTER 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 ADAPTER 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 15710040 ↗
• MalfunctionMar 8, 2022Break; Break

  ACCORDING TO THE REPORTER, THE CATHETER WAS IMPLANTED IN THE PATIENT FOR 4 TO 5 MONTHS. THE REPAIR KIT WAS USED ON (B)(6) 2022 (TO REPAIR THE CATHETER AND TEGO WAS SCREWED ON BY HAND ON THE LUMEN OF THE REPAIR KIT). DURING NORMAL USAGE, A CRACK WAS OBSERVED AT THE LUMEN LEVEL OF THE VENOUS LUER ADAPTER USING TEGO. THE ADAPTERS WERE USUALLY TIGHTENED BY HAND; THEY NEVER USED TOOLS/INSTRUMENTS TO LOOSEN OR TIGHTEN THE DEVICE AND THEY DID NOT TIGHTEN THE TEGO TOO MUCH. THERE WAS NO LEAK. 70% ALCOHOL PER IFU WAS THE CLEANING AGENT USED ON THE DEVICE AND USED TO CLEAN THE ADAPTERS. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE AND FLUSHING WAS PERFORMED WITH GOOD RESULT. BLOODLINES WERE BEING UTILIZED WITH THE DEVICE ASIDE FROM TEGO. THE CATHETER WAS NOT REPLACED. WHEN THEY SAW THAT THE LUMEN OF THE REPAIR KIT WAS BROKEN, THEY TOOK IT OFF AND REPLACED IT WITH ANOTHER REPAIR KIT LUMEN TO RESOLVE THE ISSUE. PROCEDURE WAS COMPLETED. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THE PATIENT WAS IN STABLE C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13693907 ↗
• MalfunctionFeb 21, 2018Break; Break

  ACCORDING TO THE REPORTER, THE RED AND BLUE ADAPTERS SHOWED HAIRLINE CRACKS AT THE THREAD OF THE ADAPTER WHEN ATTACHING A LUER-LOCK SYRINGE. THIS WAS DISCOVERED PRE-OPERATIVELY AND WAS NOT USED ON A PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7285615 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092797. One submission often covers many models, so check the product and lot details in each record.

• Z-1955-2019 · Apr 29, 2019 · Terminated
  MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009 8813793013 8813794005 8813794009 8813816005 8813816009 8813817005 8813817009 8815668007 8815668011 881