BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK TIP

    MDR report key: 11600694 · Received April 1, 2021

    Report

    Report Number
    1213809-2021-00200
    Event Type
    Malfunction
    Date Received
    April 1, 2021
    Date of Event
    March 8, 2021
    Report Date
    March 17, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: ONE PHOTO OF TWO 10ML BLISTER PACKS WAS RECEIVED AND EVALUATED. ONE PACKAGE WAS CONFIRMED TO BE FROM BATCH 8213944 AND ONE PACKAGE HAD NO VISIBLE BATCH OR EXPIRATION DATE. THE MISSING BATCH AND EXPIRATION CANNOT BE CONFIRMED BASED ON THE EVIDENCE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED AND NOT RECEIVED. IT WAS UNCLEAR IF THE PRODUCTS IN THE PHOTO WERE FROM THE SAME BATCH AS THE PRODUCT WITH NO INFORMATION MAY HAVE BEEN MADE PRIOR TO THE UNIQUE DEVICE IDENTIFIER MANDATE. 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. 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. INVESTIGATION CONCLUSION: THE MISSING BATCH AND EXPIRATION CANNOT BE CONFIRMED BASED ON THE EVIDENCE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED AND NOT RECEIVED. IT WAS UNCLEAR IF THE PRODUCTS IN THE PHOTO WERE FROM THE SAME BATCH AS THE PRODUCT WITH NO INFORMATION MAY HAVE BEEN MADE PRIOR TO THE UDI MANDATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD SYRINGE LUER-LOK¿ TIP EXPERIENCED NO LABEL OR MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 302995, BATCH NO: 8213944. BD POSIFLUSH SYRINGES RECEIVED WITHOUT EXPIRATION / LOT INFORMATION PRINTED ON ALL SAMPLES. THIS WAS OBSERVED WITH AT LEAST ONE SAMPLE FROM ABOUT 10 OF 30 SHELF BOXES THE CUSTOMER RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498172 BD SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8213944

    Patients

    Seq Age Sex Outcome Treatment
    1