BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ LUER-LOK SYRINGE

    MDR report key: 15663860 · Received October 24, 2022

    Report

    Report Number
    1911916-2022-00579
    Event Type
    Malfunction
    Date Received
    October 24, 2022
    Date of Event
    September 28, 2022
    Report Date
    November 9, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY IT WAS REPORTED THERE IS EXTRA PLASTIC ON THE LUER OF THE SYRINGE. TO AID IN THE INVESTIGATION, TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTOS SHOW A SYRINGE BARREL WITH FLASH AT THE LUER TIP. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. IT COULD BE POSSIBLE THE FLASH SHOWN IN THE PHOTOS IS AN IMPERFECTION AS THERE IS A SPECIFICATION THAT ALLOWS A MAX OF FLASH. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301035, LOT NUMBER 2040680. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED, AND WITHOUT THE PHYSICAL SAMPLE ANALYSIS WE ARE NOT ABLE TO CONFIRM WHETHER THE FLASH IS WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT THE BD¿ LUER-LOK SYRINGE EXPERIENCED EXCESS PLASTIC AT THE LUER-LOK HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: EXCESS PLASTIC AT THE LUER-LOK HUB

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ LUER-LOK SYRINGE EXPERIENCED EXCESS PLASTIC AT THE LUER-LOK HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: EXCESS PLASTIC AT THE LUER-LOK HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378934 BD¿ LUER-LOK SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 2040680

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown