BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE

    MDR report key: 10188111 · Received June 24, 2020

    Report

    Report Number
    1920898-2020-00724
    Event Type
    Malfunction
    Date Received
    June 24, 2020
    Date of Event
    June 3, 2020
    Report Date
    July 1, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249107
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED TWO (2) LOOSE 0.3ML BD INSULIN SYRINGES. CONSUMER REPORTED FOUND 4 SYRINGES TOOK OFF SHIELD NEEDLE HUB STAYED IN SHIELD. BOTH RETURNED SYRINGES WERE EXAMINED, AND BOTH EXHIBITED A NEEDLE HUB/SHIELD ASSEMBLY SEPARATED FROM THE SYRINGE BARREL; NO DAMAGE TO THE BARREL TIPS WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 9210500 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION (B)(4) NOTED FOR OUT OF SPEC SHIELD PULL. 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: L2L DISPATCH #75252 WAS FOR RAISED HUBS. THE GUIDE WAS OUT OF ADJUSTMENT. CORRECTIVE ACTION: THE GUIDE WAS ADJUSTED. CAPA#1630423 WAS INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE HUB SEPARATED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:324910 BATCH NO: 9210500. IT WAS REPORTED THAT WHEN NEEDLE SHIELD WAS REMOVED THE NEEDLE HUB REMAINED IN THE SHIELD.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE HUB SEPARATED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:324910 BATCH NO: 9210500. IT WAS REPORTED THAT WHEN NEEDLE SHIELD WAS REMOVED THE NEEDLE HUB REMAINED IN THE SHIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654529 BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324910 9210500 00382903249107

    Patients

    Seq Age Sex Outcome Treatment
    1 Other