BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 21GA 1-1/2IN

    MDR report key: 19920780 · Received August 6, 2024

    Report

    Report Number
    3002682307-2024-00157
    Event Type
    Malfunction
    Date Received
    August 6, 2024
    Date of Event
    July 11, 2024
    Report Date
    September 12, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903044320
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304432 AND LOT NUMBER 220809. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS SAMPLES WERE UNAVAILABLE FOR RETURN, TWENTY (20) RETAINED SAMPLES WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR REVIEW. THE NEEDLES WERE ASSEMBLED WITH A DISCARDIT 2 ML SYRINGE AND LIQUID WAS FOUND TO MOVE NORMALLY THROUGH THE CANNULA WITH NO SIGNS OF CLOGGING. ALSO, THE NEEDLES WERE POSITIONED ONTO THE SYRINGE WITH A SLIGHTLY ROTATIONAL MOVEMENT AND NO SIGNS OF DEFECTIVE HUB CONNECTION WERE IDENTIFIED NOR WERE ANY SIGNS OF LEAKAGE DETECTED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THIS REPORTED INCIDENT. REGARDING THE REPORT OF CLOGGED NEEDLE, INSPECTIONS FOR OCCLUDED CANNULA CONDITION ARE PERFORMED AS PART OF THE ROUTINE IN-PROCESS INSPECTIONS AFTER ASSEMBLY. IN CERTAIN CIRCUMSTANCES, THE DRUG USED CAN BECOME DEPOSITED WITHIN THE CANNULA, CAUSING THE NEEDLE TO BLOCK DUE TO CRYSTALLIZATION. OCCLUSION IS MOST LIKELY TO OCCUR IF THE DRUG REMAINS IN THE NEEDLE FOR AN EXTENDED PERIOD OF TIME, WHICH ALLOWS THE DRUG TO CRYSTALLIZE OR BE DEPOSITED ON THE INNER SURFACE OF THE NEEDLE. REGARDING THE REPORT OF DEFECTIVE HUB CONNECTION, AS WE ARE UNABLE TO DUPLICATE OR REPRODUCE THE INDICATED FAILURE MODE AND DUE TO UNAVAILABILITY OF SAMPLE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IF THIS ISSUE WERE TO REOCCUR, WE WOULD GREATLY APPRECIATE THE OPPORTUNITY TO REVIEW THE AFFECTED SAMPLE. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    TOGETHER WITH A PHARMACY THAT IS FAMILIAR WITH INJECTIONS, THE INEXPERIENCED PATIENT RE-SUSPENDED THE PRODUCT AND STARTED THE INJECTION. IT WAS MENTIONED THAT THE ENCLOSED NEEDLE WAS FIRMLY ATTACHED/SCREWED IN PROPERLY. WITH VERY SLOW PRESSURE ON THE PLUNGER, SOME LIQUID CAME OUT OF THE FRONT OF THE ATTACHED NEEDLE. HOWEVER, AS THE PRESSURE WAS THEN INCREASED TO ACHIEVE A NORMAL INJECTION SPEED, THE NEEDLE BLOCKED AND THEN THE CANNULA FLEW OFF. A SMALL VOLUME THEN ESCAPED FROM SYRINGE. THE PHARMACY THEN USED ONE OF THEIR OWN INJECTION NEEDLES (SAME SIZE). THE INJECTION WORKED WITH THIS NEEDLE AND THE REMAINING VOLUME WAS INJECTED. THE PACK IS STILL IN THE PHARMACY, THE NEEDLE WILL ALSO BE INCLUDED.

    Description of Event or Problem · 0

    RESPONSE RECEIVED ON 08-AUG-2024: NO PATIENT IMPACT WAS REPORTED TO FERRING THE RECONSTITUTION WAS CARRIED OUT WITH THE LLAS ATTACHED TO THE SYRINGES. BEFORE ATTACHING THE GREEN NEEDLE (WHICH LATER BLOCKED), THE LLA WAS REMOVED FROM THE SYRINGE(S) AND THE NEEDLE WAS ATTACHED DIRECTLY TO THE SYRINGE, I.E. WITHOUT TURNING. THE ENTIRE NEEDLE THEN BLOCKED AND FLEW OFF. THEN THE PHARMACY USED ANOTHER NEEDLE TO CONTINUE THE INJECTION WITHOUT ANY PROBLEMS. THE PATIENT MISSED PARTLY THE DOSE (A SMALL VOLUME THEN ESCAPED FROM SYRINGE). NO OTHER PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1646394 NEEDLE 21GA 1-1/2IN NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 220809 00382903044320

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown