BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 31GA 6MM 10 BAG 500 SLA

    MDR report key: 11283870 · Received February 5, 2021

    Report

    Report Number
    1920898-2021-00150
    Event Type
    Malfunction
    Date Received
    February 5, 2021
    Date of Event
    January 12, 2021
    Report Date
    April 16, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES WERE RETURNED THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTOS PROVIDED. ONE PHOTO OF 1 LOOSE 0.5ML BD INSULIN SYRINGE WAS PROVIDED. THE CUSTOMER REPORTED THAT WHEN SHE REMOVED THE SAFETY SHIELD FROM THE PLUNGER, THE PRESSURE BUTTON WAS STUCK IN THE SHIELD. THE PHOTO WAS EXAMINED, AND IT WAS OBSERVED THAT THE PLUNGER ROD WAS FRACTURED AT THE THUMB PRESS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0020455. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. ROOT CAUSE: MAINTENANCE DISPATCH (L2L) WAS REVIEWED, AND A DISPATCH WAS OPENED THAT COULD CAUSE PLUNGER DAMAGE. WAS CREATED FOR PLUNGER SCREW JAMS. THE PLUNGERS ARE PUT INTO A BIN WHERE THEY INDIVIDUALLY TRANSPORT DOWN A SCREW RAIL PRIOR TO BEING ASSEMBLED INTO A SYRINGE. AIR JETS CONTROL THE FLOW OF THE PLUNGERS ENTERING THE SCREW RAIL. WHEN MORE THE ONE PLUNGER ENTERS THE SCREW RAIL, A JAM MAY OCCUR. THE ASSEMBLY MACHINE IS PROGRAMMED STOP UNTIL THE JAM HAS BEEN CLEARED. ANY AFFECTED PRODUCT IS REMOVED AND SCRAPPED. DEPENDING ON THE SEVERITY OF THE JAM, THE PLUNGER HEAD COULD BE WEAKENED AND POTENTIALLY BREAK WHEN USED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SYRINGE 0.5ML 31GA 6MM 10 BAG 500 SLA WAS DAMAGED DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE CAREGIVER GOT IN CONTACT REPORTING A QUALITY ISSUE, SHE REPORTED THAT SHE USES THE SYRINGES TO APPLY INSULIN IN HER DOG, AND WHEN SHE REMOVED THE SAFETY SHIELD FROM THE PLUNGER, THE PRESSURE BUTTON WAS STUCK IN THE SHIELD. DESPITE OF IT, SHE COULD APPLY. THE ISSUE OCCURRED WITH ONLY ONE SYRINGE FROM THE BATCH."

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE: (B)(6). 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 A SYRINGE 0.5ML 31GA 6MM 10 BAG 500 SLA WAS DAMAGED DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE CAREGIVER GOT IN CONTACT REPORTING A QUALITY ISSUE, SHE REPORTED THAT SHE USES THE SYRINGES TO APPLY INSULIN IN HER DOG, AND WHEN SHE REMOVED THE SAFETY SHIELD FROM THE PLUNGER, THE PRESSURE BUTTON WAS STUCK IN THE SHIELD. DESPITE OF IT, SHE COULD APPLY. THE ISSUE OCCURRED WITH ONLY ONE SYRINGE FROM THE BATCH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181946 SYRINGE 0.5ML 31GA 6MM 10 BAG 500 SLA PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0020455

    Patients

    Seq Age Sex Outcome Treatment
    1