BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES WITH BD ULTRA-FINE NEEDLE

    MDR report key: 10133817 · Received June 9, 2020

    Report

    Report Number
    1920898-2020-00645
    Event Type
    Malfunction
    Date Received
    June 9, 2020
    Date of Event
    May 20, 2020
    Report Date
    June 25, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903282890
    PMA / PMN Number
    K170386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL?: YES. RETURNED TO MANUFACTURER ON: 6/8/2020. H.6. INVESTIGATION: CUSTOMER RETURNED ONE (1) 31GX8MM, 1ML BD INSULIN SYRINGE FROM AN OPEN POLYBAG FROM LOT 9063823. CONSUMER REPORTED 1 SYRINGE WITH A HOLE AT 45 MARKER; FOUND THIS HOLE WHILE DRAWING UP INSULIN AND IT LEAKED OUT FROM THIS HOLE THIS MORNING. THE RETURNED SYRINGE WAS EXAMINED, AND IT WAS OBSERVED THAT THE BARREL WAS CRACKED. THE CRACKED BARREL WOULD BE THE CAUSE OF THE LEAKAGE REPORTED BY THE CUSTOMER. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9063823. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200812920] NOTED FOR CRACKED BARREL. THERE WERE THREE (3) NOTIFICATIONS [200812809, 200813473, 200812377] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. PROCESS SUMMARY: THE AUTOMATIC SYRINGE ASSEMBLY MACHINE FEEDS 1ML SYRINGE COMPONENTS (BARREL, STOPPER, PLUNGER, AND CAP) AND ASSEMBLES THESE COMPONENTS. THIS MACHINE CONSISTS OF A BARREL-CLEANING DIAL, LUBRICATION DIAL, ONE PLUNGER/STOPPER ASSEMBLY DIAL AND ONE SYRINGE ASSEMBLY DIAL AND VARIOUS INSPECTION AND TRANSFER DIALS. NOTIFICATION 200812920 WAS OPENED DURING THE PRODUCTION OF THIS BATCH FOR CRACKED BARRELS AT THE ASSEMBLY OPERATION. THE BARRELS WERE NOT FEEDING PROPERLY INTO THE PREP DIAL DUE TO MISALIGNMENT. THE ISSUE WAS RESOLVED BY REALIGNING THE DEAD BLOCKS TO THE PREP DIAL AND RAILS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLES EXPERIENCED A FAILURE TO CONTAIN MEDICATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FOUND 1 SYRINGE WITH A HOLE AT 45 MARKER. FOUND THIS HOLE WHILE DRAWING UP INSULIN AND IT LEAKED OUT FROM THIS HOLE THIS MORNING. SHE WAS INJECTING THE INSULIN BACK INTO THE VIAL AND GRABBED A NEW SYRINGE FOR HER INJECTION. LOT #: 9063823D CATALOG#: 328289 DATE OF EVENT: (B)(6) 2020.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLES EXPERIENCED A FAILURE TO CONTAIN MEDICATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FOUND 1 SYRINGE WITH A HOLE AT 45 MARKER. FOUND THIS HOLE WHILE DRAWING UP INSULIN AND IT LEAKED OUT FROM THIS HOLE THIS MORNING. SHE WAS INJECTING THE INSULIN BACK INTO THE VIAL AND GRABBED A NEW SYRINGE FOR HER INJECTION. LOT #: 9063823D, CATALOG#: 328289, DATE OF EVENT: (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600286 BD INSULIN SYRINGES WITH BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328289 9063823 00382903282890

    Patients

    Seq Age Sex Outcome Treatment
    1 Other