BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK¿ TIP

    MDR report key: 7329894 · Received March 11, 2018

    Report

    Report Number
    1213809-2018-00125
    Event Type
    Malfunction
    Date Received
    March 11, 2018
    Date of Event
    February 21, 2018
    Report Date
    April 3, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903029952
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: LOT # PROVIDED: 8002653. MEDICAL DEVICE EXPIRATION DATE: 12/31/2022. DEVICE MANUFACTURE DATE: 01/02/2018. INVESTIGATION RESULTS: ONE PHOTO RECEIVED AT BD (B)(4) DEPICTING FOUR 10ML BLISTERPACKS, CONFIRMED TO BE FROM BATCH NUMBER 8002653 (P/N 302995). PHOTO WAS VISUALLY EVALUATED. A SLIT WAS OBSERVED ON THE TOP WEB OF ALL FOUR SYRINGES. BASED ON THE PHOTO EVALUATION, PACKAGE SEAL INTEGRITY POOR WAS CONFIRMED. DHR REVIEW FOR BATCH 8002653 (P/N 302995): MANUFACTURING DATES: 01/13/2018 TO 01/14/2018. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 8002653 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE NOT REQUIRED BASED ON SEVERITY AND OCCURRENCE LEVEL DEFINED FOR THIS COMPLAINT. BASED ON THE SEVERITY AND OCCURRENCE A CAPA IS NOT NECESSARY. 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.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACKAGING OF THE BD SYRINGE LUER-LOK¿ TIP WAS BRITTLE AND DAMAGED. FOUND BEFORE USE. NO REPORTS OF SERIOUS INJURY OR MEDIAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172878 BD SYRINGE LUER-LOK¿ TIP SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8002653 00382903029952

    Patients

    Seq Age Sex Outcome Treatment
    1 Other