BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE

    MDR report key: 8755515 · Received July 2, 2019

    Report

    Report Number
    1920898-2019-00610
    Event Type
    Malfunction
    Date Received
    July 2, 2019
    Date of Event
    June 15, 2019
    Report Date
    August 13, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00311917048154
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (1) 31G X 8MM, 0.3ML WALGREENS INSULIN SYRINGE FROM LOT 8232713. CONSUMER REPORTED 1 SYRINGE STOPPER DEFORMED AND WILL NOT ALLOW PLUNGER TO MOVE. THE RETURNED SAMPLE WAS EXAMINED, AND EXHIBITED A DAMAGED/DISFIGURED STOPPER. THE DAMAGED STOPPER WOULD BE THE CAUSE FOR DIFFICULTY WHEN MOVING THE PLUNGER ROD. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8232713. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE FOUR (4) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. PROCESS SUMMARY: AUTOMATIC SYRINGE ASSEMBLY MACHINE, WHICH FEEDS 3/10CC, 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. ROOT CAUSE: THE SILICONE LEAKED OUT OF THE SILICONE TANK AND HOSE BECAUSE OF A DEFECTIVE FITTING. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSULIN¿ SYRINGE STOPPER IS DEFORMED AND MAKES THE PLUNGER DIFFICULT TO MOVE DURING USE. NO DATE/TIME OR PATIENT INFORMATION WAS GIVEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 928858 BATCH NO. 8232713. IT WAS REPORTED THAT STOPPER IS DEFORMED AND WILL NOT ALLOW PLUNGER TO MOVE. VERBATIM: SYRINGE 31G 3/10ML FOUND 1 SYRINGE STOPPER DEFORMED AND WILL NOT ALLOW PLUNGER TO MOVE.

    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 BD INSULIN SYRINGE STOPPER IS DEFORMED AND MAKES THE PLUNGER DIFFICULT TO MOVE DURING USE. NO DATE/TIME OR PATIENT INFORMATION WAS GIVEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 928858 BATCH NO. 8232713. IT WAS REPORTED THAT STOPPER IS DEFORMED AND WILL NOT ALLOW PLUNGER TO MOVE. VERBATIM: SYRINGE 31G 3/10ML FOUND 1 SYRINGE STOPPER DEFORMED AND WILL NOT ALLOW PLUNGER TO MOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548788 BD INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8232713 00311917048154

    Patients

    Seq Age Sex Outcome Treatment
    1 Other