BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL

    MDR report key: 10631862 · Received October 5, 2020

    Report

    Report Number
    1213809-2020-00692
    Event Type
    Malfunction
    Date Received
    October 5, 2020
    Date of Event
    September 11, 2020
    Report Date
    October 8, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096269
    PMA / PMN Number
    K980580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE PHOTO AND ONE 1ML SYRINGE IN AN OPENED BLISTER PACK FROM BATCH 8308851 (P/N 309626) WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THE STOPPER INSIDE THE SYRINGE WAS NOT ATTACHED AND WEDGED BETWEEN THE BOTTOM OF THE PLUNGER ROD AND BARREL WALL, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE INSECURE STOPPER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 8308851 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. 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 THE SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL STOPPER WAS FOUND MISALIGNED AND DAMAGED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BLACK RUBBER END OF PLUNGER NOT SEATED PROPERLY. SQUISHED DOWN SIDE OF WHITE PLUNGER INSIDE SYRINGE."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL STOPPER WAS FOUND MISALIGNED AND DAMAGED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BLACK RUBBER END OF PLUNGER NOT SEATED PROPERLY. SQUISHED DOWN SIDE OF WHITE PLUNGER INSIDE SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089645 SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309626 8308851 30382903096269

    Patients

    Seq Age Sex Outcome Treatment
    1 Other