BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 29G 12.7MM 10BAG 500 EU

    MDR report key: 11809764 · Received May 11, 2021

    Report

    Report Number
    1920898-2021-00542
    Event Type
    Malfunction
    Date Received
    May 11, 2021
    Date of Event
    April 13, 2021
    Report Date
    May 25, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-05-05. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (2) LOOSE 1/2CC, 12.7MM, 29G SYRINGES IN A SHELF CARTON FROM LOT # 0090585. CUSTOMER STATES THAT THERE ARE LOOSE PLASTIC PARTICLES IN FRONT OF THE PLUNGER ON ANOTHER SYRINGE. BOTH RETURNED SYRINGES WERE EXAMINED AND ONE SAMPLE EXHIBITED A HARD PLASTIC PARTICLE IN THE FLUID PATH OF THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0090585. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SYRINGE 0.5ML 29G 12.7MM 10BAG 500 EU HAD FOREIGN MATTER BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "LOOSE PLASTIC PARTICLES IN FRONT OF THE PLUNGER ON ANOTHER SYRINGE".

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYRINGE 0.5ML 29G 12.7MM 10BAG 500 EU HAD FOREIGN MATTER BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "LOOSE PLASTIC PARTICLES IN FRONT OF THE PLUNGER ON ANOTHER SYRINGE"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705705 SYRINGE 0.5ML 29G 12.7MM 10BAG 500 EU PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0090585

    Patients

    Seq Age Sex Outcome Treatment
    1