BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5CCM 30GA 8MM BLS 100BX/500 AP

    MDR report key: 20071381 · Received August 26, 2024

    Report

    Report Number
    3024508819-2024-00294
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Report Date
    November 12, 2024
    Manufacturer
    EMBECTA MEDICAL I LLC - HOLDREGE, NE
    Product Code
    FMF
    PMA / PMN Number
    UNKNOWN
    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 SECTION H6 (COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS & INVESTIGATION CONCLUSIONS). INVESTIGATION SUMMARY: NO PHYSICAL SAMPLES WERE RECEIVED HOWEVER THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTO(S) PROVIDED. 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 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. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    ACCOUNT NAME ¿DKSH MALAYSIA SDN BHD MATERIAL DESCRIPTION ¿ BD SY 0.5ML 8MM 30G BLS 100S MATERIAL# 326725 . MATERIAL LOT# 3142108. COMPLAINT DESCRIPTION ¿ DAMAGE ON ARRIVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42127 SYRINGE 0.5CCM 30GA 8MM BLS 100BX/500 AP SYRINGE, PISTON FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 326725 3142108

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose