BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFE-CLIP¿ NEEDLE CLIPPING DEVICE

    MDR report key: 18341408 · Received December 15, 2023

    Report

    Report Number
    2243072-2023-02194
    Event Type
    Malfunction
    Date Received
    December 15, 2023
    Date of Event
    November 21, 2023
    Report Date
    January 11, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903282357
    PMA / PMN Number
    K943683
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OEM MANUFACTURER:THE MANUFACTURING LOCATION FOR THIS PRODUCT IS [FLEXTRONICS]. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE INITIAL REPORTER THAT THE BD SAFE-CLIP¿ NEEDLE CLIPPING DEVICE WAS NOT CLIPPING. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: NEEDLE CLIPPERS (LOT#3003001) PATIENT OBTAINED FROM RETAIL PHARMACY APPROX 2-3 MONTHS AGO ARE NOT CUTTING NEEDLE TIPS OFF AS PER DESIGN. SEEMS TO BE BENDING THE TIP, SOMETIMES BREAKING IT THROUGH BENDING FORCE, OTHER TIMES NOT AT ALL. ALSO SEEMS TO BE A NEEDLE TIP JAMMED INSIDE NEEDLE ENTRY POINT OF CLIPPERS (UNABLE TO REMOVE).

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE INITIAL REPORTER THAT THE BD SAFE-CLIP¿ NEEDLE CLIPPING DEVICE WAS NOT CLIPPING. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: NEEDLE CLIPPERS (LOT#3003001) PATIENT OBTAINED FROM RETAIL PHARMACY APPROX 2-3 MONTHS AGO ARE NOT CUTTING NEEDLE TIPS OFF AS PER DESIGN. SEEMS TO BE BENDING THE TIP, SOMETIMES BREAKING IT THROUGH BENDING FORCE, OTHER TIMES NOT AT ALL. ALSO SEEMS TO BE A NEEDLE TIP JAMMED INSIDE NEEDLE ENTRY POINT OF CLIPPERS (UNABLE TO REMOVE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1548487 BD SAFE-CLIP¿ NEEDLE CLIPPING DEVICE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 3003001 00382903282357

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown