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N/A 4330Recalls & reported problems

Carefusion 2200, Inc · Manometer, 550 ml Three-Way Stopcock · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403076145), received between Aug 23, 2021 and Sep 27, 2021 — classified as 2 injuries.

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

Most reported problems

Device problems

  • Fluid/Blood Leak2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjurySep 27, 2021Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED MANOMETERS THAT ARE USED ARE LEAKING WHEN CONNECTED TO THE STOPCOCK. EMAIL VERBATIM: "GOOD AFTERNOON, THE MANOMETERS THAT ARE USED IN THE DEPARTMENT OF NEURORADIOLOGY, LOT# 000141691, ARE LEAKING WHEN CONNECTED TO THE STOPCOCK. THIS MAY CAUSE AN INCORRECT READING WHEN MEASURING PRESSURES. REFERENCE # (B)(4). DESCRIPTION IS "MANOMETER, 550 ML, THREE  WAY STOPCOCK. COMPANY IS CAREFUSION. HOSPITAL STOREROOM BIN # IS (B)(4). WE DO HAVE ANOTHER LOT THAT DOES NOT LEAK, # (B)(4). BUT WE ONLY HAVE 2. I WILL NEED MORE SHORTLY, BUT NOT SURE WHAT LOT WILL COME UP FROM STOREROOM. I AM THANKFUL FOR ANY GUIDANCE YOU CAN GIVE ME. THANK YOU".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12536485 ↗
  • InjuryAug 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PRODUCT LEAKED. PRODUCT LEAKING. PER RESPONSE EMAIL: THE MANOMETER WAS LEAKING AT THE CONNECTION TO THE STOPCOCK. THERE WERE NO CRACKS OR BREAKS IN MANOMETERS THAT COULD BE VISUALIZED. INITIALLY WE TRIED USING ANOTHER MANOMETER , WHICH DID THE SAME THING. WE THEN HAD TO USE MORE FORCE FOR A TIGHTER SEAL. THAT SEEMED TO RESOLVE THE ISSUE BUT THEN IT IS DIFFICULT TO DISCONNECT MANOMETER/STOPCOCK. THE IMPACT TO PATIENT IS THAT IF IT LEAKS, WE CANNOT RECORD AN ACCURATE OPENING PRESSURE AND MANY OF THESE PATIENTS HAVE LUMBAR PUNCTURES ORDERED ALMOST EXCLUSIVELY FOR OPENING PRESSURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12353491 ↗

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