BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL 21GA 1-1/2IN BIL LAX

    MDR report key: 18691493 · Received February 12, 2024

    Report

    Report Number
    9614033-2024-00012
    Event Type
    Malfunction
    Date Received
    February 12, 2024
    Date of Event
    August 22, 2023
    Report Date
    February 1, 2024
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    07501073024991
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLES OR PHOTOS WERE RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON PREVIOUS INVESTIGATIONS WITH THE BATCH NUMBERS INVOLVED, POSSIBLE ROOT CAUSE FOR STOPPER SEPARATION IS ASSOCIATED WITH DAMAGED AIR VALVES THAT DISPENSE SILICONE. VALVES WILL BE UPDATED. POSSIBLE ROOT CAUSE FOR LOOSE NEEDLE IS ASSOCIATED WITH INSUFFICIENT APPLICATION OF EPOXY IN THE ASSEMBLY OF THE CANNULA-HUB. EPOXY IS AN ADHESIVE USED TO JOIN THE CANNULA AND HUB. CHANGE OF THE EPOXY DOSING VALVE WILL BE IMPLEMENTED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 10ML LL 21GA 1-1/2IN BIL LAX STOPPER SEPARATED FROM THE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM PORTUGUESE TO ENGLISH: HIPODERMIC SYRINGE WITH 10 ML NEEDLE, REFERENCE 302499, BATCH 1337220 AND 2132714, AT THE END OF WHICH IT IS KNOWLEDGEABLE AND EVALUATED BY THE MANUFACTURER AND SENDS US THE CORRESPONDING RESPONSE TO RESPOND TO THE CUSTOMER, DEPENDING ON THE RELIABILITY OF THE CASE. WE HAVE NOT YET RECEIVED A DESCRIPTION OF THE EVENT. THIS INFORMATION WILL BE REQUESTED FROM THE CUSTOMER DURING FOLLOW-UP. 10.OCT.2023 L.FREIRE INFORMATION RECEIVED ON JAN, 19 2024 WHEN UNCOVERING THE 10CC SYRINGE IT IS EVIDENT THAT THE RUBBER OF THE PLUNGER IS LOOSE, WHEN PACKAGING THE MEDICATION IT COMES OUT - BATCH NUMBER 2132714 WHEN USING THE SYRINGE TO PACKAGE MEDICATION, IT IS EVIDENT THAT THE NEEDLE IS LOOSE FROM THE GREEN HUB, WHICH IS WHY IT DOES NOT GENERATE A VACUUM AND DOES NOT ASPIRATE THE MEDICATION. BATCH NUMBER 1337220.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765704 BD SYRINGE 10ML LL 21GA 1-1/2IN BIL LAX SYRINGE FMF BECTON DICKINSON DE MEXICO 2132714 07501073024991

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown