BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE NEEDLE 30G X 1/2

    MDR report key: 10665216 · Received October 12, 2020

    Report

    Report Number
    1911916-2020-00952
    Event Type
    Malfunction
    Date Received
    October 12, 2020
    Date of Event
    September 1, 2020
    Report Date
    September 24, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051060
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305106 AND LOT NUMBER 0022949. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED DEFECT. TO AID IN THE INVESTIGATION, FIVE HUNDRED PHYSICAL SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE SAMPLES WERE RECEIVED IN SHELF BOXES, ONE HUNDRED SAMPLES IN EACH BOX AND ALL IN THE SEALED PACKAGING BLISTERS. TWENTY RANDOM SAMPLES FROM EACH BOX, A TOTAL OF ONE HUNDRED SAMPLES, WERE PULLED FOR INVESTIGATION. EACH SAMPLE WAS CONNECTED TO A SYRINGE WITH A SALINE SOLUTION AND ALL HAD A NORMAL FLOW. BASED ON THE INVESTIGATION RESULTS, THE RANDOM SAMPLES PULLED DID NOT SHOW THE SYMPTOM REPORTED BY THE CUSTOMER AND AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD PRECISIONGLIDE¿ NEEDLE 30G X 1/2 EXPERIENCED CLOGGED/BLOCKED NEEDLES WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305106 BATCH NO: 0022949. EVENT DESCRIPTION: THE CUSTOMER REPORTS THAT THE NEEDLES APPEARED TO BE BLOCKED/CLOGGED OR OTHERWISE UNABLE TO PROPERLY ADMINISTER INJECTIONS. NO MEDICAL ATTENTION REQUIRED. IF ANY FURTHER INFORMATION IS OBTAINED WE WILL ADVISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131554 BD PRECISIONGLIDE NEEDLE 30G X 1/2 HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305106 0022949 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other