BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE

    MDR report key: 14116316 · Received April 14, 2022

    Report

    Report Number
    9610847-2022-00138
    Event Type
    Malfunction
    Date Received
    April 14, 2022
    Date of Event
    March 15, 2022
    Report Date
    April 28, 2022
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    30382903097020
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1351533; MEDICAL DEVICE EXPIRATION DATE: 30-SEP-2026; DEVICE MANUFACTURE DATE: 28-JAN-2022. MEDICAL DEVICE LOT #: 2021820; MEDICAL DEVICE EXPIRATION DATE: 30-SEP-2026; DEVICE MANUFACTURE DATE: 03-FEB-2022. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE EIGHT SAMPLES SUBMITTED FOR EVALUATION FOR THE REPORTED BATCH 1351533. OF THE SAMPLES, THREE WERE RETURNED FOR THE REPORTED FAILURE OF SILICONE VISIBLE. THE REPORTED ISSUE OF SILICONE VISIBLE WAS CONFIRMED UPON INSPECTION OF THE SAMPLES SINCE ALL THREE WERE FOUND TO HAVE STRINGS OF SILICONE PRESENT. BD DETERMINED THAT THE CAUSE OF THE FAILURE WAS ASSOCIATED TO THE ASSEMBLY PROCESS OF THE PRODUCT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. OUR QUALITY ENGINEER INSPECTED THE SEVEN SAMPLES SUBMITTED FOR EVALUATION FOR THE REPORTED BATCH 2021820. OF THE SAMPLES, THREE WERE RETURNED FOR THE REPORTED FAILURE OF SILICONE VISIBLE. THE REPORTED ISSUE OF SILICONE VISIBLE WAS CONFIRMED UPON INSPECTION OF THE SAMPLES SINCE ALL THREE WERE FOUND TO HAVE STRINGS OF SILICONE PRESENT. BD DETERMINED THAT THE CAUSE OF THE FAILURE WAS ASSOCIATED TO THE ASSEMBLY PROCESS OF THE PRODUCT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD LUER-LOK¿ SYRINGE EACH FROM LOTS 1351533 AND 2021820 HAD EXCESSIVE SILICONE ON THEM. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "EXCESSIVE SILICONE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD LUER-LOK¿ SYRINGE EACH FROM LOTS 1351533 AND 2021820 HAD EXCESSIVE SILICONE ON THEM. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "EXCESSIVE SILICONE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173522 BD LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 309702 SEE SECTION H10 30382903097020

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown