BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿SYRINGE LUER-LOK¿

    MDR report key: 7267099 · Received February 13, 2018

    Report

    Report Number
    1213809-2018-00063
    Event Type
    Malfunction
    Date Received
    February 13, 2018
    Date of Event
    December 26, 2017
    Report Date
    March 29, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096580
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TWO PHOTOS WERE RECEIVED OF 3ML PACKAGED SYRINGE REPORTED TO BE FROM BATCH #7212683 (P/N 309658). THE PHOTOS WERE VISUALLY EVALUATED. THE SYRINGE WAS OBSERVED TO HAVE BLACK FOREIGN MATTER IN THE BARREL FLANGE AND BARREL TIP. THE FOREIGN MATTER APPEARED EMBEDDED AND LARGER THAN LEVEL 3 IN SIZE, WHICH IS A REJECTABLE CONDITION AT BD CANAAN. HOWEVER, WITHOUT A SAMPLE IT WAS NOT POSSIBLE TO IDENTIFY THE FM FROM THE TWO PHOTOS PROVIDED. DHR REVIEW FOR BATCH 7212683 (P/N 309658): MANUFACTURING DATES: 08/18/2017 TO 08/19/2017. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7212683 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. BASED ON THE SAMPLE EVALUATION BD CANAAN WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE. ROOT CAUSE IS UNDETERMINED AND CAPA IS NOT REQUIRED BASED ON SEVERITY AND OCCURRENCE LEVEL DEFINED FOR THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 DURING USE OF THE BD PLASTIPAK¿SYRINGE LUER-LOK¿ BLACK SPOTS ARE PRESENT INSIDE THE HUB AND BARREL OF ONE LUER LOK. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110388 BD PLASTIPAK¿SYRINGE LUER-LOK¿ SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7212683 30382903096580

    Patients

    Seq Age Sex Outcome Treatment
    1 Other