BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1 ML BD¿ SLIP TIP SYRINGE WITH ATTACHED NEEDLE 26 G X 3/8 IN.

    MDR report key: 6829024 · Received August 29, 2017

    Report

    Report Number
    1213809-2017-00081
    Event Type
    Malfunction
    Date Received
    August 29, 2017
    Date of Event
    August 4, 2017
    Report Date
    November 7, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION: SAMPLE EVALUATION: TWO PHOTOS WERE RECEIVED BY BD CANAAN AND WERE EVALUATED. THE REPORTED PRODUCT WAS 1ML S/T WITH NEEDLE FROM BATCH #7031971 (P/N (B)(4)). THE SAMPLE IS THE PHOTOS WAS MANIPULATED ¿ FILLED WITH 4.5ML OF UNIDENTIFIED LIQUID. A SMALL DARK FM WAS OBSERVED BETWEEN THE NEEDLE HUB AND THE SLIP TIP OF THE SYRINGE. FROM THE PHOTOS IT IS NOT POSSIBLE TO IDENTIFY THE FM. IT IS ALSO NOT POSSIBLE TO CONCLUDE WHETHER THE FM WAS PRESENT IN THE SAMPLE PRIOR TO BEING MANIPULATED. DHR/QN REVIEW FOR BATCH #7031971 (P/N (B)(4)): MANUFACTURING DATES: 2/28/17 - 3/02/17. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7031971 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. BASED ON THE SAMPLE EVALUATION: CONFIRMED: BD CANAAN WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE: UNDETERMINED - BASED ON THE INVESTIGATION RESULTS TO DATE, THE SOURCE OF FM COULD NOT BE DETERMINED AND ROOT CAUSE NOT FOUND. BASED ON THE SEVERITY ASSIGNED TO THIS COMPLAINT AND THE RESULTS OF THE COMPLAINT LOT HISTORY CHECK, CAPA IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS LIQUID FOUND IN A 1 ML BD¿ SLIP TIP SYRINGE WITH ATTACHED NEEDLE 26 G X 3/8 IN., INTRADERMAL BEVEL, STERILE, SINGLE USE BEFORE USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606451 1 ML BD¿ SLIP TIP SYRINGE WITH ATTACHED NEEDLE 26 G X 3/8 IN. HYPODERMIC SYRINGE W/ NEEDLE FMF BECTON DICKINSON MEDICAL SYSTEMS 7031971

    Patients

    Seq Age Sex Outcome Treatment
    1 Other