BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP

    MDR report key: 10557477 · Received September 18, 2020

    Report

    Report Number
    1920898-2020-01265
    Event Type
    Malfunction
    Date Received
    September 18, 2020
    Date of Event
    August 31, 2020
    Report Date
    October 5, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED PHOTOS OF 3/10CC SYRINGES. CUSTOMER STATES THAT THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE HUB. THE PHOTOS WERE EXAMINED AND EXHIBITED THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. UNABLE TO PERFORM DHR CHECK FOR NEEDLE HUB SEPARATES DUE TO UNKNOWN LOT NUMBER. PROCESS SUMMARY: AUTOMATIC SYRINGE ASSEMBLY MACHINE, WHICH FEEDS 0.3ML, SYRINGE COMPONENTS (BARREL, STOPPER, PLUNGER, NEEDLE ASSEMBLY & CAP) AND ASSEMBLES THESE COMPONENTS. THIS MACHINE CONSISTS OF A BARREL CLEANING DIAL, LUBRICATION DIAL, PLUNGER/STOPPER ASSEMBLY DIAL, SYRINGE ASSEMBLY DIAL, AND VARIOUS INSPECTIONS AND TRANSFER DIALS. DHR, L2L DISPATCHES, LOGBOOK ENTRIES COULD NOT BE LOOKED AT AS NO LOT NUMBER WAS GIVEN. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. CAPA#1630423 WAS INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP EXPERIENCED HUB SEPARATION FROM THE DEVICE PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE HUB (LOW-DOSE SYRINGE).

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP EXPERIENCED HUB SEPARATION FROM THE DEVICE PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE HUB (LOW-DOSE SYRINGE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022035 SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP SYRINGE FMF BD MEDICAL - DIABETES CARE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other