BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE CLIPPING DEVICE SAFE CLIP

    MDR report key: 19147124 · Received April 19, 2024

    Report

    Report Number
    3022699058-2024-00001
    Event Type
    Malfunction
    Date Received
    April 19, 2024
    Report Date
    July 12, 2024
    Manufacturer
    EMBECTA MEDICAL II LLC - PARSIPPANY, NJ
    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

    CORRECTION TO: H6 (COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS) INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. 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. 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

    CONSUMER REPORTED THAT HER SAFE CLIP NEEDLE CLIPPER IS NOT WORKING, STATED THAT THE NEEDLE WILL NOT GO INTO THE SAFE CLIP. CONSUMER STATED THAT SHE HAD THE SAFE CLIP FOR AWHILE BUT IT IS NOT FULL BUT IT JUST STOPPED WORKING. LOT #: 1308206. CATALOG #: 328235. DATE OF EVENT: UNKNOWN. SAMPLES: AVAILABLE - SENDING MAIL KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1686883 NEEDLE CLIPPING DEVICE SAFE CLIP NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA MEDICAL II LLC - PARSIPPANY, NJ 328235 1308206 00382903282357

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown