N/A 4306CRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885403057069), received between Oct 18, 2021 and Nov 7, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Leak/Splash” (3 reports).

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jan 20, 2022Open, Classified

   Due to lumbar puncture tray manometer failure mode of leaking and mating issues.

   Z-0796-2022 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE STOPCOCK LEAKS FLUID FROM THE CONNECTION WITH THE MANOMETER. LUMBAR PUNCTURE KIT, STOPCOCK LEAKS FLUID FROM THE CONNECTION WITH THE MANOMETER, AND DOES NOT GIVE A RELIABLE PRESSURE READING. DR. HAD TO CONTINUE CASE AND COMPLETE DESPITE THE LEAKING DURING THE OPENING AND CLOSING PRESSURE. NO HARM OR PAIN REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12760748 ↗
• InjuryNov 7, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE STOPCOCK LEAKS FLUID FROM THE CONNECTION WITH THE MANOMETER. VERBATIM: LUMBAR PUNCTURE KIT, STOPCOCK LEAKS FLUID FROM THE CONNECTION WITH THE MANOMETER, AND DOES NOT GIVE A RELIABLE PRESSURE READING. DR. HAD TO CONTINUE CASE AND COMPLETE DESPITE THE LEAKING DURING THE OPENING AND CLOSING PRESSURE. NO HARM OR PAIN REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12760334 ↗
• InjuryNov 2, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE STOPCOCK LEAKS FLUID. VERBATIM: THE 3-WAY STOPCOCK USE TO CONNECT THE TUBING TO THE MANOMETRY COLUMN LEAKS FLUID FROM THE BOTTOM. INACCURATE MEASUREMENTS OF INTRATHECAL PRESSURE. WAS THERE A NEED TO REPEAT THE PROCEDURE? SINCE THE INTRACRANIAL PRESSURE COULD NOT BE MEASURED ACCURATELY AND THE PROCEDURE WAS ORDERED FOR THAT REASON, THE PROCEDURE WOULD NEED TO BE REPEATED, BECAUSE NO ACCURATE MEASUREMENT COULD BE OBTAINED. WAS THE SPECIMEN CONTAMINATED? NO. WHAT WAS DONE TO RESOLVE THE ISSUE? WE TRIED TO USE A DIFFERENT 3-WAY THAN THE ONE USED IN THE KIT BUT IT ALSO LEAKED, BECAUSE THE MANOMETER COLUMN COULD NOT CONNECT TO IT PROPERLY. WAS THERE ANY CRACKS OR BREAKAGE NOTICED AT THE CONNECTION POINT? NO CRACK WAS NOTED AND THE LEAK APPEARS TO BE FROM INSIDE THE 3 WAY ITSELF. THIS HAPPENED WITH MULTIPLE KITS, SO IT IS NOT AN ISSUE OF ONE DEVICE BEING DAMAGED. IS THERE A PHOTO OR SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE FOR THE EVALUATION? WE DON¿T HAVE A PICTURE, BUT IT WOULD ESSENTIALLY SHOW CSF DRIPPING FROM THE BOTTOM OF THE 3 WAY WHEN EVERYTHING IS CONNECTED PROPERLY. PLEASE PROVIDE ADDRESS SAMPLE WILL BE RETURNING FROM, IF AVAILABLE. LOMA LINDA UNIVERS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12740193 ↗
• InjuryOct 18, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT LUMBAR PUNCTURE TRAYS ARE LEAKING. VERBATIM: HELLO, PLEASE SEE THE ATTACHED FORMS FOR CEDARS SINAI FOR SOME RECENT FAILURES/COMPLAINTS WITH OUR LUMBAR PUNCTURE TRAYS, ITEM 4306C. PHOTO BELOW SHOWS WHERE THEY EXPERIENCED LEAKAGE IS OCCURRING. I HAVE SAMPLES TO SEND BACK FOR BOTH INCIDENTS. CUSTOMER REPORTS LEAKING FROM CONNECTION OF STOPCOCK OUT THE BOTTOM (PICTURE CAN BE PROVIDED TO POINT OUT WHERE ON STOPCOCK), SAYS THAT THE PRESSURE READING REPORTED BY THE MANOMETER IS NOT RELIABLE ON OPENING OR CLOSING. DR. SAYS HE IS UNCERTAIN OPENING CLOSING PRESSURE READING IS ACCURATE. OTHER COMMENTS: MULTIPLE EVENTS OCCURRED ON THIS LOT NUMBER PRIOR TO REPORTING THESE TWO, THIS IS JUST THE FIRST ONES THEY REMEMBERED TO REPORT AND SAVE THE STOPCOCK FOR ME. THEY ALSO THINK THE MANOMETER MAY BE PART OF THE PROBLEM BUT FORGOT TO SAVE THEM. HAVE HAD A TOTAL OF 15 EVENTS ON THIS LOT NUMBER IDENTICAL TO THIS EVENT REPORTED. WAS THERE A NEED TO REPEAT THE PROCEDURE? - NO. WAS THE SPECIMEN CONTAMINATED? - NO. WHAT WAS DONE TO RESOLVE THE ISSUE? ¿ CONTINUE THE REST OF THE PROCEDURE DESPITE THE LEAKING FROM THE CONNECTION WITH THE MANOMETER AND THE STOPCOCK. WAS THERE ANY CRACKS O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12650147 ↗