BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿

    MDR report key: 6761764 · Received August 2, 2017

    Report

    Report Number
    1213809-2017-00053
    Event Type
    Malfunction
    Date Received
    August 2, 2017
    Date of Event
    July 12, 2017
    Report Date
    September 6, 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
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: ONE PHOTO WAS RECEIVED BY BD (B)(4) DEPICTING A 3ML SYRINGE FILLED WITH ~0.8ML OF UNIDENTIFIED SOLUTION AND COVERED WITH A RED CAP. A SINGLE PIECE OF THIN ELONGATED FM APPROXIMATELY 3/8¿ IN LENGTH COULD BE SEEN INSIDE THE FLUID. THE FM COULD NOT BE IDENTIFIED FROM THE PHOTO PROVIDED. THE SAMPLE WAS REPORTED TO BE FROM BATCH #6203651 (P/N 309658). A REVIEW OF THE DEVICE HISTORY RECORD SHOWED ALL VISUAL INSPECTIONS AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 6203651 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. ALTHOUGH THE CUSTOMER'S REPORTED DEFECT WAS CONFIRMED, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. 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

    (B)(6). 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 A PARTICLE WAS FOUND DISSOLVED IN ONE OF THE BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿. THE SOLUTION WAS DISCARDED BEFORE USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540482 BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿ SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 6203651

    Patients

    Seq Age Sex Outcome Treatment
    1 Other