BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VEO¿ INSULIN SYRINGE WITH BD ULTRA-FINE 6MM NEEDLE

    MDR report key: 13053173 · Received December 21, 2021

    Report

    Report Number
    1920898-2021-01328
    Event Type
    Malfunction
    Date Received
    December 21, 2021
    Date of Event
    August 6, 2021
    Report Date
    December 15, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249114
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. BD WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. CORRECTIVE/PREVENTATIVE ACTION (CAPA) HAS BEEN INITIATED. THESE SAMPLES WERE ORIGINALLY RETURNED AS UNRELATED SAMPLES AS A PART OF (B)(4), (MFR REPORT#: 1920898-2021-00955). A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1060364. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200945734] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES RECEIVED, BD WAS ABLE TO CONFIRM THE INDICATED FAILURE OF NEEDLE HUB SEPARATION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. MANUFACTURING (HOLDREGE) WILL BE NOTIFIED OF THIS ISSUE. CAPA (B)(4) HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD VEO¿ INSULIN SYRINGE WITH BD ULTRA-FINE 6MM NEEDLES EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER HAS RETURNED SAMPLES IN WHICH THE NEEDLE HUBS HAVE SEPARATED FROM THE SYRINGES. ADDITIONAL SAMPLES WERE NOT ORIGINALLY REPORTED AND FOUND DURING INVESTIGATION. SAMPLES WILL BE TESTED FOR NEEDLE HUB SEPARATION OUTSIDE THE ORIGINALLY REPORTED NEEDLE POINT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1949821 BD VEO¿ INSULIN SYRINGE WITH BD ULTRA-FINE 6MM NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324911 1060364 00382903249114

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown