BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 ML BD¿ SLIP TIP SYRINGE

    MDR report key: 6918476 · Received October 5, 2017

    Report

    Report Number
    1213809-2017-00163
    Event Type
    Malfunction
    Date Received
    October 5, 2017
    Date of Event
    September 6, 2017
    Report Date
    December 27, 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
    DR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. UDI: (B)(4).

    Additional Manufacturer Narrative · 1

    DHR/QN REVIEW FOR BATCH 6062842 (P/N 304406): MANUFACTURING DATES: 3/12/2016 ¿ 3/13/2016. BATCH SIZE WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7150644 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. ONE PHOTO WAS RECEIVED BY BD (B)(4) AND EVALUATED. THE PHOTO DEPICTED A SINGLE ASSEMBLED 10ML SYRINGE. THE STOPPER IN THE SAMPLE WAS NOT FULLY ATTACHED TO THE CROWN OF THE PLUNGER ROD. THIS IS INDICATIVE OF MISS-ASSEMBLY DURING THE MANUFACTURING PROCESS. NO ISSUES RELATED TO THE DEFECT WERE RECORDED DURING MANUFACTURE OF THIS BATCH WHICH IMPLIES THE DEFECT WAS AN ISOLATED INCIDENT. 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. BASED ON THE SAMPLE EVALUATION: CONFIRMED: BD (B)(4) WAS ABLE TO 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. CONCLUSION: THE ROOT CAUSE FOR THIS INCIDENT HAS BEEN DETERMINED TO BE MIS-ASSEMBLY DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A CRACK IN THE BARREL OF A 10 ML BD¿ SLIP TIP SYRINGE, AS WELL AS AN INSECURE STOPPER ON THE PLUNGER, BEFORE USE. NO REPORTED MEDICAL INTERVENTION OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698687 10 ML BD¿ SLIP TIP SYRINGE SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 6062842

    Patients

    Seq Age Sex Outcome Treatment
    1 Other