MAHURKAR 8817145005Recalls & reported problems
Mozarc Medical US LLC · Acute Dual Lumen Catheter,Straight Extensions with 2 Sealing Caps · Class 2
All models of MAHURKAR (81)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521005013), received between Jun 17, 2021 and Jun 17, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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.
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 17, 2021Material Puncture/Hole; Detachment of Device or Device Component; Material Puncture/Hole; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE CATHETER HAD BEEN IN PLACE FOR 3 WEEKS AND DURING THE DIALYSIS TREATMENT WHILE THE PATIENT WAS IN ICU, THE CATHETER CRACKED AT THE JUNCTION OF THE TUBING AND THE BLUE PORT JUST ABOVE THE CLAMP (BUT THE LUER ADAPTER DID NOT DETACH FROM THE EXTENSION TUBE). BLOOD STARTED LEAKING WHILE CATHETER WAS IN USE. CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) WAS THE ONE BEING CONNECTED. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE AND FLUSHING WAS DONE WITH PATENT RESULT. CHLORHEXIDINE GLUCONATE (CHG)/ALCOHOL WAS USED TO CLEAN THE ADAPTERS AND NO OINTMENT WAS APPLIED TO THE AREA. THE CATHETER WAS NOT REPAIRED PREVIOUSLY AND TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THERE WERE NO OTHER PRODUCT BEING UTILIZED WITH THE DEVICE AND HANDS WERE USED TO TIGHTEN THE ADAPTERS. THE CLAMPS WERE NOT MOVED TO A NEW LOCATION AFTER EACH TREATMENT. THE CATHETER WAS REMOVED AND THE CHILD WAS PUT UNDER GENERAL ANESTHESIA TO HAVE ANOTHER CATHETER PLACED. THERE WAS MINIMAL BLOOD LOSS AS A RESULT OF THE EVENT AND BLOOD TRANSFUSION WAS NOT REQUIRED. THE PATIENT HAD NO INJURY AND REMAINED IN THE ICU.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12017707 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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