BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1911916-2018-00660

    MDR report key: 8065313 · Received November 13, 2018

    Report

    Report Number
    1911916-2018-00660
    Event Type
    Malfunction
    Date Received
    November 13, 2018
    Date of Event
    November 7, 2018
    Report Date
    February 14, 2019
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A DHR WAS PERFORMED AND THERE WAS NO DOCUMENTATION OF ISSUES FOR THE COMPLAINT OF BATCH # 8082749 DURING THIS PRODUCTION RUN. ONE PHOTO WAS PROVIDED. IT SHOWS A SYRINGE WITH A CRACKED BARREL AT THE 15ML MARK. ROOT CAUSE POSSIBLE IS FROM A JAM AT THE PLUNGER ROD- RUBBER STOPPER ASSEMBLY PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ SYRINGE WITH BD LUER-LOK¿ TIP HAD A CRACKED BARREL. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD¿ SYRINGE WITH BD LUER-LOK¿ TIP HAD A CRACKED BARREL. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other