BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 21036784 · Received December 30, 2024

    Report

    Report Number
    1213809-2024-01012
    Event Type
    Malfunction
    Date Received
    December 30, 2024
    Date of Event
    May 13, 2024
    Report Date
    December 6, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096467
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE SAMPLE OF A 5ML LUER-LOK SYRINGE (P/N ¿ 309646) BATCH 4010739 WAS RECEIVED AND EVALUATED. THE SAMPLE RECEIVED WITH THE UNSEALED PACKAGE HAS DAMAGE TO THE BARREL, AND WHEN TESTED LEAKED PAST THE STOPPER. THE CONDITIONS OBSERVED ARE NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE BARREL DAMAGED AND LEAKAGE PAST STOPPER DEFECTS IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 4010739 SHOWING NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. 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

    MATERIAL#: 309646. BATCH NUMBER#: 4010739. POST INVESTIGATION FINDINGS REVEALED THAT THE BD LUER-LOK BARREL / FLANGE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT 5ML SYRINGE WAS LEAKING UPON USE. SAVED PACKAGE WRAPPER. IMMEDIATE ESCALATION TO PHARMACY ADMINISTRATION. ASSOCIATE DID NOT UTILIZE SYRINGE ON COMPOUNDING PATIENT DOSE. VERBATIM#: 5ML SYRINGE WAS LEAKING UPON USE. SAVED PACKAGE WRAPPER. IMMEDIATE ESCALATION TO PHARMACY ADMINISTRATION. ASSOCIATE DID NOT UTILIZE SYRINGE ON COMPOUNDING PATIENT DOSE. PRODUCT NUMBER - 309646. LOT NUMBER(S): 4010739.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2420286 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4010739 30382903096467

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown