BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE CLIPPING DEVICE SAFE CLIP

    MDR report key: 12519698 · Received September 23, 2021

    Report

    Report Number
    2243072-2021-02374
    Event Type
    Malfunction
    Date Received
    September 23, 2021
    Date of Event
    August 26, 2021
    Report Date
    October 11, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903282357
    PMA / PMN Number
    K943683
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: THE CUSTOMER PROVIDED LOT # 6221064. THIS DOES NOT MATCH THE CATALOG NUMBER PROVIDED. D.4. MEDICAL DEVICE LOT #: 0008001. D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.4. DEVICE MANUFACTURE DATE: 2020-01-29. 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 RELATED 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 SITUATION ANALYSIS (SA) IS REQUIRED AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD NEEDLE CLIPPING DEVICE SAFE CLIP HAD THE SAFECLIP NOT CLIPPING OR JAMMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED BD SAFE-CLIP IS NOT CUTTING NEEDLES STATING THAT THE BLADE OR CUTTING MECHANISM IS DULL AND IN ATTEMPTING TO USE DEVICE 3 TIMES HAS HAD TO USE EXCESSIVE FORCE TO GET PRODUCT TO WORK. DATE OF EVENT : UNKNOWN. SAMPLES : AVAILABLE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(4). MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BD NEEDLE CLIPPING DEVICE SAFE CLIP HAD THE SAFECLIP NOT CLIPPING OR JAMMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONSUMER REPORTED BD SAFE-CLIP IS NOT CUTTING NEEDLES STATING THAT THE BLADE OR CUTTING MECHANISM IS DULL AND IN ATTEMPTING TO USE DEVICE 3 TIMES HAS HAD TO USE EXCESSIVE FORCE TO GET PRODUCT TO WORK. DATE OF EVENT: UNKNOWN. SAMPLES: AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1419452 BD NEEDLE CLIPPING DEVICE SAFE CLIP NEEDLE CLIPPING DEVICE FMI BECTON DICKINSON 328235 SEE H.10 00382903282357

    Patients

    Seq Age Sex Outcome Treatment
    1