Lumbar Catheter Accessory Kit 910121Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10381780034124), received between Oct 6, 2021 and Apr 21, 2022 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Advance” (2 reports).

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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2022Leak/Splash; Leak/Splash

  A FACILITY REPORTED THAT THE LUMBAR CATHETER (910121) WAS LEAKING FROM THE MIDDLE OF THE CATHETER. THE SURGEON USED ANOTHER LOT OF THE SAME ITEM CODE: 910121 TO COMPLETE THE PROCEDURE. THE EVENT DID NOT LEAD TO INCREASED SURGERY TIME OR PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14167610 ↗
• InjuryFeb 17, 2022Material Fragmentation; Failure to Advance; Material Fragmentation; Failure to Advance

  MEDWATCH (MW5104457) WAS RECEIVED WITH THE FOLLOWING INFORMATION: "DURING ATTEMPTED LUMBAR DRAIN PLACEMENT, CATHETER UNABLE TO CONTINUE ADVANCING UPON CATHETER REMOVAL. PART OF THE CATHETER WAS RETAINED."

  Patient problems: Foreign Body In Patient

  MAUDE report 13549028 ↗
• InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS 4 OF 4 REPORTS LINKED TO MFG REPORT NUMBERS: 2648988-2021-00018, 2648988-2021-00020, 9612007-2021-00038. A FACILITY REPORTED THAT LUMBAR CATHETER (910121) WAS OBSERVED LEAKING ON ARRIVAL TO UNIT, DRESSING CHANGED WITH STERILE TECHNIQUE WAS DONE. PATIENT HAD SEVERE HEADACHE. FIRST CEREBROSPINAL FLUID (CSF) CULTURE WAS CLEAN, THEN ON (B)(6) 2021, NEUTROPHILS WENT FROM 2 TO 77, PROTEIN / GLUCOSE WAS FINE. PATIENT ON ANCEF, CULTURE/SENSITIVITY SHOWED NO GROWING ORGANISMS. PATIENT WAS LATER DISCHARGED ON (B)(6) 2021.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 12920170 ↗
• InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS 2 OF 4 REPORTS LINKED TO MFG REPORT NUMBERS: 2648988-2021-00018, 2648988-2021-00020, 9612007-2021-00039. A FACILITY REPORTED THAT THE LUMBAR CATHETER (910121) WAS INSERTED FOR A LUMBAR DRAIN PROCEDURE AND PATIENT LATER DEVELOPED CEREBROSPINAL FLUID (CSF) LEAK AT THE INSERTION SITE. THE LUMBAR CATHETER WAS REMOVED AND STITCH WAS APPLIED DUE TO THE LEAKAGE. NO SURGICAL DELAY WAS REPORTED.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 12918487 ↗
• InjuryOct 6, 2021Failure to Advance

  DURING ATTEMPTED LUMBAR DRAIN PLACEMENT, CATHETER UNABLE TO CONTINUE ADVANCING. UPON CATHETER REMOVAL, PART OF THE CATHETER WAS RETAINED. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12590154 ↗