MAHURKAR 8888340637Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521057029), received between Jan 3, 2023 and Jan 3, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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

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 28, 2023Class IOpen, Classified

   Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus

   Z-2380-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, FEMORAL LINE CATHETER WAS INSERTED ON (B)(6) 2022 IN MEDICAL ICU (INTENSIVE CARE UNIT) FOR PLASMAPHERESIS. PATIENT WAS TRANSFERRED TO WARD 56 ON (B)(6) 2022 NIGHT. STAFF NURSE IN CHARGE OF PATIENT FOUND MILD LEAKING SURROUNDING THE CATHETER CONNECTOR. WHEN REVIEWED, IT WAS NOTED THAT THE CONNECTOR HEAD/LUER ADAPTER HAD FRACTURED AND BROKE OFF/DETACHED FROM THE CATHETER. THERE WAS LEAK ON THE MIDDLE (INFUSION LUMEN). PRIOR TO THE ISSUE, THE CATHETER WAS NOT REPAIRED PREVIOUSLY (AS IT WAS A NEW SET). NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE (AS CLARIFIED WITH PHYSICIANS WHO INSERTED THE CATHETER). IT WAS FLUSHED BY PHYSICIANS WHO INSERTED THE LINE, NO ISSUE OBSERVED, THUS WENT AHEAD TO SUTURE DOWN THE CATHETER FOR ANCHORING. 3-WAY CONNECTOR ATTACHED TO THE CATHETER UPON TRANSFER TO WARD 56 WAS THE OTHER PRODUCT BEING UTILIZED WITH THE DEVICE. TEGO WAS NOT UTILIZED. NO EXCESSIVE FORCE APPLIED ON THE DEVICE. NO MANIPULATION BY WARD 56 NURSES UPON TRANSFER. ALCOHOL SWAB TYPICALLY USED TO CLEAN THE HUB BEFORE CONNECTING 3 WAY CATHETER. THERE WAS APPROXIMATELY 50MLS OF BLOOD LOSS. BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16091341 ↗