BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK¿ TIP

    MDR report key: 7309389 · Received March 2, 2018

    Report

    Report Number
    1213809-2018-00076
    Event Type
    Malfunction
    Date Received
    March 2, 2018
    Date of Event
    February 7, 2018
    Report Date
    March 21, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903029953
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A 10ML SYRINGE AND AN OPENED 10ML SYRINGE PACKAGE WITH A PAPER CLIP WERE RECEIVED, CONFIRMED TO BE FROM LOT 7212586. SAMPLES WERE VISUALLY EVALUATED, STRING OF SILICONE SHOWN WHEN PULLING THE PLUNGER DOWN FROM THE TOP. PRODUCT DEFECT CONFIRMED BASED ON SAMPLE EVALUATION PERFORMED. DHR REVIEW FOR BATCH 7212586: MANUFACTURING DATES: 08/17/2017 TO 08/21/2017. BATCH QUANTITY WAS (B)(4). ASSEMBLY RECORDS WERE REVIEWED AS PART OF THIS DHR REVIEW. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. SILICONE WEIGHT TESTING WAS PERFORMED AS PER REQUIREMENT WITH ALL TEST RESULTS WITHIN ACCEPTABLE RANGE PER PRODUCT SPECIFICATION. BATCH 7212586 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. SILICONE WEIGHT TEST. 9 INDIVIDUAL TESTS OF 12 SAMPLES EACH FOR A TOTAL OF 108 SAMPLES, ALL SAMPLES PASSED WITH NO ISSUES OBSERVED DURING PRODUCTION. INVESTIGATION CONCLUSION: POTENTIAL SILICONE GUN MALFUNCTION DURING ASSEMBLY PROCESS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ¿LOOSE GEL¿ WAS FOUND INSIDE THE SYRINGE OF A BD SYRINGE LUER-LOK¿ TIP PRIOR TO USE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155007 BD SYRINGE LUER-LOK¿ TIP SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7212586 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 Other