BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE

    MDR report key: 16010899 · Received December 19, 2022

    Report

    Report Number
    1911916-2022-00764
    Event Type
    Malfunction
    Date Received
    December 19, 2022
    Date of Event
    November 30, 2022
    Report Date
    December 2, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903096534
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: IT WAS REPORTED THE SYRINGE IS NOT CONNECTING CORRECTLY. TO AID IN THE INVESTIGATION, FOURTEEN SAMPLES IN SEALED PACKAGING BLISTERS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED WITH A 10X MAGNIFIER LENS, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH SAMPLE WAS THEN FILLED WITH 10ML OF SALINE SOLUTION AND CONNECTED TO THREE DIFFERENT NEEDLE ASSEMBLIES: 18G, 22G AND 27G. NO LEAKAGE OR ANY OTHER DEFECT WAS OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT NUMBER 0118593. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED, AND A PROBABLE ROOT CAUSE COULD NOT BE OFFERED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 15 BD LUER-LOK¿ SYRINGE WAS DIFFICULT TO CONNECT TO MATING COMPONENT AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN USING THE MNF# 309653 SYRINGES PROVIDED BY (B)(6), WHEN PUNCTURING THE IV BAG (BUT NOT YET INSERTING IP INTO THE IV BAG!), SOME DROPS LEAK ALONG THE SYRINGE MNF# 309653.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2544279 BD LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 0118593 00382903096534

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown