BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL S/C 200

    MDR report key: 10411652 · Received August 14, 2020

    Report

    Report Number
    1213809-2020-00534
    Event Type
    Malfunction
    Date Received
    August 14, 2020
    Date of Event
    July 23, 2020
    Report Date
    September 14, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903029953
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE SAMPLE ¿ A REPORTEDLY 10ML SYRINGE ¿ WAS RECEIVED. THE SAMPLE WAS RECEIVED IN A DOUBLE WRAPPED BIOHAZARD BAG WITH ADDITIONAL GAUZE OR OTHER WRAPPING INSIDE THE BAG AROUND THE SAMPLE. A NOTE ACCOMPANIED THE SAMPLE STATED IT WAS CONTAMINATED, ALONG WITH VERBATIM WHICH INDICATED IT WAS BONE MARROW. THE SAMPLE COULD NOT BE EVALUATED DUE TO CONTAMINATION. IT COULD ALSO NOT BE TESTED DUE TO HAVING BEEN MANIPULATED. NO REPRESENTATIVE SAMPLES FROM THE SAME LOT WERE RECEIVED FOR EVALUATION AND TESTING. THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE SAMPLE RECEIVED. SINCE NO REPRESENTATIVE SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED. REPRESENTATIVE SAMPLES WOULD BE NECESSARY FOR TESTING. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 10ML LL S/C 200 LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 302995 BATCH NO. 0062702 IT WAS REPORTED THAT THE PLUNGER AND BARREL FAILED, ALLOWING A LEAK BEHIND THE PLUNGER.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 10ML LL S/C 200 LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 302995 BATCH NO. 0062702 IT WAS REPORTED THAT THE PLUNGER AND BARREL FAILED, ALLOWING A LEAK BEHIND THE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870261 SYRINGE 10ML LL S/C 200 PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 302995 0062702 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 Other