BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE CLIPPING DEVICE SAFE CLIP

    MDR report key: 19112373 · Received April 15, 2024

    Report

    Report Number
    2243072-2024-05009
    Event Type
    Malfunction
    Date Received
    April 15, 2024
    Date of Event
    March 20, 2024
    Report Date
    July 9, 2024
    Manufacturer
    BECTON DICKNSON - FRANKLIN LAKES, NJ / 07417
    Product Code
    FMI
    UDI-DI
    00382903282357
    PMA / PMN Number
    K943683
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED TO SECTIONS B4, G6, H2, H3, AND H11. CORRECTIONS MADE TO SECTIONS H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, & INVESTIGATION CONCLUSIONS) AND H8 (USAGE OF DEVICE). INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. THIS IS THE 2ND 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. EMBECTA WAS NOT 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. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED.

    Description of Event or Problem · 0

    PET OWNER REPORTED HAS 1 SAFE CLIP DEVICE THAT WILL NOT CLIP THE 31G NON BD INSULIN SYRINGE. LOT # 2031001. CATALOG# 328235. DATE OF EVENT 03-20-2024. SAMPLE STATUS AWAITING SAMPLE =(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1406591 NEEDLE CLIPPING DEVICE SAFE CLIP NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKNSON - FRANKLIN LAKES, NJ / 07417 328235 2031001 00382903282357

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown