BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1 ML BD¿ SLIP TIP SYRINGE WITH ATTACHED NEEDLE 27 G X 1/2 IN

    MDR report key: 6761462 · Received August 2, 2017

    Report

    Report Number
    1213809-2017-00048
    Event Type
    Malfunction
    Date Received
    August 2, 2017
    Date of Event
    June 21, 2017
    Report Date
    September 19, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DHR REVIEW FOR BATCH 7031969 (P/N 309623): MANUFACTURING DATES: 2/19/2017 ¿ 2/22/2017. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7031969 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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. THE INVESTIGATION CONCLUDED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE BASED ON THE SEVERITY ASSIGNED TO THIS COMPLAINT AND THE RESULTS OF THE COMPLAINT LOT HISTORY CHECK, CAPA IS NOT REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FDA NOTIFIED: THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON 06/29/2017 VIA MEDWATCH # MW5070634. A SAMPLE IS NOT AVAILABLE FOR EVALUATION. HOWEVER, A NO SAMPLE INVESTIGATION AND DEVICE HISTORY RECORD REVIEW WILL BE COMPLETED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A CEMENT LIKE SUBSTANCE AND DISCOLORATION ON A 1 ML BD¿ SLIP TIP SYRINGE WITH ATTACHED NEEDLE 27 G X 1/2 IN. BEFORE USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540288 1 ML BD¿ SLIP TIP SYRINGE WITH ATTACHED NEEDLE 27 G X 1/2 IN CONVENTIONAL SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7031969

    Patients

    Seq Age Sex Outcome Treatment
    1 Other