BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 0.5ML 30GA 8MM 10BAG 500 CA

    MDR report key: 8537409 · Received April 22, 2019

    Report

    Report Number
    1920898-2019-00369
    Event Type
    Malfunction
    Date Received
    April 22, 2019
    Date of Event
    April 4, 2019
    Report Date
    May 24, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CUSTOMER RETURNED (1) PHOTO OF A 0.5ML BD INSULIN SYRINGE. CUSTOMER REPORTED THE PLUNGER LOOKS AS IF IT WAS MELTED TO THE INSIDE OF THE SYRINGE AND THERE WAS NO SAFETY CAP ON THE BACK BY THE PLUNGER. THE RETURNED PHOTO WAS EXAMINED AND THE SYRINGE EXHIBITED A DISFIGURED STOPPER, THUS CONFIRMING THE ALLEGED DEFECT. FROM THE PHOTO RETURNED, THERE WAS NO EVIDENCE OF A PLUNGER CAP MISSING, THEREFORE THE ALLEGED ISSUE COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8113613. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200754355] NOTED FOR SMEARED STOPPERS/ MISSING SHIELDS. CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (DISFIGURED STOPPER) UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (MISSING PLUNGER CAP) POSSIBLE ROOT CAUSE FOR DISFIGURED STOPPER: THIS CONDITION IS REFERRED TO AS A ROLLED STOPPER WHICH CAN OCCUR DURING THE ASSEMBLY PROCESS, WHEN THE PLUNGER ROD IS BEING ASSEMBLED IN THE BARREL AND THERE IS INADEQUATE (NOT ENOUGH) LUBE PRESENT IN THE BARREL ID (INNER DIAMETER) AND OR THE STOPPER ITSELF DOES NOT HAVE ENOUGH LUBE ON IT. AS A RESULT, THE STOPPER DOES NOT MOVE FREELY IN THE BARREL AND CAN BECOME STUCK AND DEFORMED. THERE IS ALSO THE POSSIBILITY THAT THE STOPPER STARTS OUT BEING MISALIGNED ON THE END OF THE PLUNGER ROD AND THEN GETS ROLLED AS IT IS BEING INSERTED INSIDE THE BARREL. ROLLED STOPPERS CAN ALSO BE CAUSED BY PARTIALLY PEELING OFF THE STOPPER BEFORE INSERTION INTO THE SYRINGE BARREL. AS PER SUPPLIER, IMPROPER STACKING OF RUBBER SHEETS IN AUTOCLAVE CART, CAUSING PINCHING/DEFORMITY. CAPA 122939 HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PLUNGER WAS DAMAGED AND THERE WAS NO SAFETY CAP WITH A BD SYRINGE¿ 0.5ML 30GA 8MM 10BAG 500 CA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I FOUND AN ODD ANOMALY IN MY BAG OF BD ULTRA-FINE II SYRINGES (SHORT). THE PLUNGER LOOKS AS IF IT WAS MELTED TO THE INSIDE OF THE SYRINGE AND THERE WAS NO SAFETY CAP ON THE BACK BY THE PLUNGER. IT WAS VERY ODD TO SEE SOMETHING LIKE THAT FOR THE FIRST TIME AFTER USING YOUR PRODUCTS FOR MY DIABETES FOR OVER 25 YEARS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLUNGER WAS DAMAGED AND THERE WAS NO SAFETY CAP WITH A BD SYRINGE¿ 0.5 ML 30 GA 8 MM 10BAG 500 CA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I FOUND AN ODD ANOMALY IN MY BAG OF BD ULTRA-FINE II SYRINGES (SHORT). THE PLUNGER LOOKS AS IF IT WAS MELTED TO THE INSIDE OF THE SYRINGE AND THERE WAS NO SAFETY CAP ON THE BACK BY THE PLUNGER. IT WAS VERY ODD TO SEE SOMETHING LIKE THAT FOR THE FIRST TIME AFTER USING YOUR PRODUCTS FOR MY DIABETES FOR OVER 25 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331595 BD SYRINGE 0.5ML 30GA 8MM 10BAG 500 CA INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 8113613

    Patients

    Seq Age Sex Outcome Treatment
    1 Other