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N/A 4302CRecalls & reported problems

Carefusion 2200, Inc · Pediatric/Infant Lumbar Puncture Tray - 22 G x 1 1/2 Inch Spinal Needle without Manometer · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885403057045), received between Aug 23, 2021 and Aug 23, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Fluid/Blood Leak1

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.

  • InjuryAug 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED BY THE HEALTH PROFESSIONAL THAT THE TUBES ARE LEAKING BECAUSE THE CAP IS NOT CLOSED TIGHTLY. PER EMAIL: WE'RE RECEIVED ADDITIONAL REPORTS OF CSF SPECIMEN TUBES LEAKING. THIS HAS ALREADY OCCURRED MULTIPLE TIMES IN OUR FACILITY THIS SUMMER. SEE BELOW FOR THE MOST RECENT INCIDENT. INCIDENT DATE: (B)(6) 2021. STAFF REPORTED 3 OUT OF THE 4 CSF TUBES WERE FAULTY. THE CAPS DO NOT CLOSE TIGHTLY, ALLOWING SPECIMENS TO LEAK OUT. PER RESPONSE EMAIL: HERE¿S WHAT I RECEIVED FROM OUR HEMONC STAFF RN¿S THIS MORNING: HOW WAS THE ISSUE RESOLVED? THE ISSUE HAS NOT RESOLVED. PER ENTRY DESCRIPTION " THE CAPS DO NOT CLOSE TIGHTLY" PLEASE CLARIFY, WAS THERE A PROBLEM WITH TUBE OR CAPS THREADING? THE LIDS DO NOT STAY CLOSED, WHEN YOU TWIST THEM SHUT THEY END UP POPPING OFF AND THE CSF IS LEAKING OUT. IT¿S LIKE THE CAP ISN¿T LOCKING IN PLACE WHEN IT¿S SCREWED ON. PLEASE CONFIRM IF THERE WAS ANY PATIENT HARM AS A RESULT OF REPORTED ISSUE. THIS AS CAUSED PATIENT HARM IN THE SENSE THAT THEIR CSF RESULTS TELL US IF THEY ARE STILL CANCER FREE IN THE SPINAL FLUID, AND IF IT LEAKS WE HAVE TO REDO THE SPINAL TAP IN SOME SITUATIONS. WAS THE SPECIMEN CONTAMINATED? SPECIMEN WAS NOT CONTAMINATED JUST

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12353487 ↗

Other Lumbar puncture tray (adult & pediatric) devices

All Lumbar puncture tray (adult & pediatric) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.