BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    MDR report key: 10083193 · Received May 22, 2020

    Report

    Report Number
    1920898-2020-00560
    Event Type
    Malfunction
    Date Received
    May 22, 2020
    Date of Event
    May 1, 2020
    Report Date
    May 5, 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
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (4) LOOSE 3/10CC SYRINGES. ALL RETURNED SYRINGES EXHIBITED THE SAME CONDITION AS SHOWN. THE INVESTIGATION BELOW REMAINS VALID. SAMPLE WILL BE FORWARDED TO MANUFACTURING ((B)(4)) ON 21MAY2020. LEVEL B INVESTIGATION: OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 5TH RELATED COMPLAINT FOR NEEDLE HUB SEPARATES ON LOT # 9210500. CUSTOMER RETURNED A PHOTOS OF A 3/10CC SYRINGE. CUSTOMER STATES THAT THE NEEDLE HUB SEPARATED INTO THE SHIELD. THE ATTACHED PHOTO WAS EXAMINED AND EXHIBITED THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. MANUFACTURING ((B)(4)) WILL BE NOTIFIED OF THIS ISSUE. 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 [200840071] NOTED FOR OUT OF SPEC SHIELD PULL. INVESTIGATION CONCLUSION: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE DESCRIPTION: ON 14 MAY 2020, (B)(4) RECEIVED PHOTO COMPLAINT. A VISUAL EVALUATION OF PHOTO FOUND (1) SYRINGE WITH NO NEEDLE ASSEMBLY ATTACHED. THERE DID NOT APPEAR TO BE ANY DAMAGE TO THE TIP OF THE BARREL, OR ANYWHERE ON THE SYRINGE. THERE WAS NO HUB INSIDE OF THE SHIELD. 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 #18413 WAS FOR RAISED HUBS. A GUIDE WAS OUT OF ADJUSTMENT. CORRECTIVE ACTION: THE GUIDE WAS ADJUSTED. RATIONALE: TIP-2019-37 WAS IMPLEMENTED ON (B)(6) 2019 FOR INCREASED SAMPLING FOR NEEDLE HUB SEPARATES IN 0.3ML. CAPA# (B)(4) HAS BEEN OPENED TO ADDRESS THIS ISSUE OF HUB SEPARATES."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HUB PULLED OUT OF THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "OUT OF THE LAST 6 SYRINGES I TRIED TO USE, 4 OF THEM WERE BROKEN. WHEN I PULL THE CAP OFF IT ALSO PULLS OFF THE NEEDLE AS WELL. I'VE HAD THIS HAPPEN BEFORE, ONCE OR TWICE HERE AND THERE, BUT THIS IS TOO MUCH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548096 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324910 9210500 00382903249107

    Patients

    Seq Age Sex Outcome Treatment
    1 Other