BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANOMETER TRAY STERILE 10/BX - 4330

    MDR report key: 12536485 · Received September 27, 2021

    Report

    Report Number
    1625685-2021-00064
    Event Type
    Injury
    Date Received
    September 27, 2021
    Date of Event
    September 8, 2021
    Report Date
    September 23, 2021
    Product Code
    KRK
    UDI-DI
    10885403076145
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) INITIAL EMDR SUBMISSION. (B)(4). NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. SHOULD YOU EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT, EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON NO SAMPLE, THE INVESTIGATION CONCLUDED, BD WAS NOT ABLE TO VERIFY THE INDICATED FAILURE.

    Description of Event or Problem · 1

    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".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1429208 MANOMETER TRAY STERILE 10/BX - 4330 MANOMETER, BLOOD-PRESSURE, VENOUS KRK 4330 UNKNOWN 10885403076145

    Patients

    Seq Age Sex Outcome Treatment
    1 Other