BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFE-CLIP

    MDR report key: 15902337 · Received December 2, 2022

    Report

    Report Number
    2243072-2022-02073
    Event Type
    Malfunction
    Date Received
    December 2, 2022
    Date of Event
    November 4, 2022
    Report Date
    February 2, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903282357
    PMA / PMN Number
    K943683
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. MEDICAL DEVICE EXPIRATION DATE: NA.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 03-JAN-2023. H6: INVESTIGATION SUMMARY INVESTIGATION SUMMARY: CUSTOMER RETURNED A SAFECLIP FROM LOT 9183033. VISUAL INSPECTION OF THE SAFECLIP FOUND SIGNS OF USE IN THE FORM OF WEAR TO THE NEEDLE CUTTER IN ADDITION TO FRAGMENTS OF OTHER NEEDLES. INSERTING A TEST PEN NEEDLE WAS NOT POSSIBLE DUE TO THE VOLUME OF MATERIAL INSIDE THE SAFECLIP PORT. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. BASED ON THE SAMPLE RECEIVED, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF THE SAFECLIP BEING UNABLE TO CUT PEN NEEDLES. THE MOST LIKELY ROOT CAUSE OF THE SAFECLIP BEING UNABLE TO CUT PEN NEEDLES IS SIGNIFICANT WEAR AND USAGE OVER TIME. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAFE-CLIP ARE NOT CLIPPING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED, PRODUCT IS NOT CLIPPING NEEDLES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAFE-CLIP ARE NOT CLIPPING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED, PRODUCT IS NOT CLIPPING NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2329254 BD SAFE-CLIP HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 328235 9183033 00382903282357

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown