BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE

    MDR report key: 10214005 · Received June 30, 2020

    Report

    Report Number
    1920898-2020-00771
    Event Type
    Malfunction
    Date Received
    June 30, 2020
    Date of Event
    June 10, 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
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED ONE (1) 0.3ML BD INSULIN SYRINGE FROM AN OPEN POLYBAG FROM LOT 9210500. CONSUMER REPORTED NEEDLE SHIELD DIFFICULT TO REMOVE; WHEN SHIELD WAS REMOVED, THE NEEDLE HUB SEPARATED AND STAYED INSIDE OF THE SHIELD. THE RETURNED SHIELD WAS EXAMINED, AND IT WAS OBSERVED THAT THE NEEDLE HUB/SHIELD ASSEMBLY WAS SEPARATED FROM THE BARREL TIP; NO DAMAGE TO THE BARREL TIP WAS OBSERVED. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE (HUB SEPARATES). 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. ROOT CAUSE: L2L DISPATCH #75252 WAS FOR RAISED HUBS. THE GUIDE WAS OUT OF ADJUSTMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE HUB SEPARATED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 324910; BATCH NO. 9210500. IT WAS REPORTED THAT NEEDLE SHIELD WAS DIFFICULT TO REMOVE AND WHEN THE SHIELD WAS REMOVED THE NEEDLE HUB SEPARATED AND STAYED INSIDE OF SHIELD.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 324910 BATCH NO. 9210500. IT WAS REPORTED THAT NEEDLE SHIELD WAS DIFFICULT TO REMOVE AND WHEN THE SHIELD WAS REMOVED THE NEEDLE HUB SEPARATED AND STAYED INSIDE OF SHIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680167 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