BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 29GA 1/2IN 7BAG 420CAS JP

    MDR report key: 10200934 · Received June 26, 2020

    Report

    Report Number
    1920898-2020-00754
    Event Type
    Malfunction
    Date Received
    June 26, 2020
    Date of Event
    June 8, 2020
    Report Date
    July 2, 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 ONE (1) LOOSE 29GX12.7MM, 1ML BD INSULIN SYRINGE. CONSUMER REPORTED A STOPPER WAS SEPARATED FROM THE PLUNGER AND THE PRODUCT COULD THUS NOT BE USED. THE RETURNED SYRINGE AS EXAMINED, AND IT WAS OBSERVED THAT THE RUBBER STOPPER WAS PROPERLY ATTACHED TO THE PLUNGER ROD. THE SYRINGE WAS TESTED FOR PLUNGER ROD MOVEMENT: THE PLUNGER ROD ASSEMBLY WAS ABLE TO MOVE PROPERLY. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED. SINCE NO DEFECTS WERE OBSERVED THE ALLEGED ISSUE COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9081523. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 1.0ML 29GA 1/2IN 7BAG 420CAS JP STOPPER WAS SEPARATED FROM THE PLUNGER. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A STOPPER WAS SEPARATED FROM THE PLUNGER AND THE PRODUCT COULD THUS NOT BE USED.

    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 1.0ML 29GA 1/2IN 7BAG 420CAS JP STOPPER WAS SEPARATED FROM THE PLUNGER. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A STOPPER WAS SEPARATED FROM THE PLUNGER AND THE PRODUCT COULD THUS NOT BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668061 SYRINGE 1.0ML 29GA 1/2IN 7BAG 420CAS JP SYRINGE FMF BD MEDICAL - DIABETES CARE 9081523

    Patients

    Seq Age Sex Outcome Treatment
    1 Other