BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFE-CLIP¿

    MDR report key: 16153018 · Received January 12, 2023

    Report

    Report Number
    2243072-2022-02334
    Event Type
    Malfunction
    Date Received
    January 12, 2023
    Date of Event
    December 22, 2022
    Report Date
    February 16, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903282357
    PMA / PMN Number
    K943683
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    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 CUSTOMER RETURNED (1) BD SAFE CLIP FROM LOT # 2040001. CUSTOMER STATES THAT THE SAFE CLIP NO LONGER CLIPS. THE RETURNED SAMPLE WAS TESTED AND WAS ABLE TO OPERATE PROPERLY WITHOUT ANY OBSERVED DEFECTS. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. EMBECTA WAS NOT ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. SEE H10.

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2031001. MEDICAL DEVICE EXPIRATION DATE: NA. DEVICE MANUFACTURE DATE: 25FEB2022. MEDICAL DEVICE LOT #: 2040001. MEDICAL DEVICE EXPIRATION DATE: NA. DEVICE MANUFACTURE DATE: 29JUN2022. THE MANUFACTURING LOCATION FOR THIS PRODUCT IS NYPRO. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED, AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SAFE-CLIP¿ IT WAS NOT CLIPPING. THIS OCCURRED ON THREE DEVICES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THE 2 SAFE CLIP DEVICES WILL NO LONGER CLIP ULTRA FINE SYRINGES OR ACCEPT THE NEEDLES IN THE SAFE CLIP HOLE. CLAIMS USED FOR ABOUT 1 MONTH WITH BOTH DEVICES.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SAFE-CLIP¿ IT WAS NOT CLIPPING. THIS OCCURRED ON THREE DEVICES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THE 2 SAFE CLIP DEVICES WILL NO LONGER CLIP ULTRA FINE SYRINGES OR ACCEPT THE NEEDLES IN THE SAFE CLIP HOLE. CLAIMS USED FOR ABOUT 1 MONTH WITH BOTH DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1527786 BD SAFE-CLIP¿ HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 328235 UNKNOWN 00382903282357

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown