BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP SYRINGE

    MDR report key: 7423300 · Received April 11, 2018

    Report

    Report Number
    1213809-2018-00225
    Event Type
    Malfunction
    Date Received
    April 11, 2018
    Date of Event
    March 29, 2018
    Report Date
    May 2, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SAMPLE EVALUATION: ONE SHELF CARTON OF SEALED 10ML PACKAGED SYRINGES WERE RECEIVED BY BD (B)(4) AND CONFIRMED TO BE FROM BATCH #8002669. THE SAMPLE WAS VISUALLY EVALUATED. THE SYRINGES CONTAINED IN THE SHELF CARTON WERE NOT IN THE SAME POSITION AS PACKAGED. SOME PACKAGES WERE IN STRIPS OF 5, WHILE OTHERS WERE FOUND ALREADY SEPARATED INTO SINGLE SYRINGES. EIGHT PACKAGED 10CC SYRINGES MANUFACTURED BY MCKESSON MEDICAL WERE ALSO FOUND MIXED IN. FIFTEEN SYRINGES WERE RANDOMLY SELECTED FOR EVALUATION. NO VISUAL DEFECTS WERE OBSERVED. EACH SYRINGE HAD RETAINING RING PRESENT. THE SYRINGES WERE THEN TESTED FOR PLUNGER PULL OUT FORCE. ALL 15 HAD A PLUNGER PULL OUT FORCE WITHIN THE SPECIFIED ACCEPTABLE RANGE PER PRODUCT SPECIFICATION. DHR REVIEW FOR BATCH 8002669: MANUFACTURING DATES: 01/21/2018 TO 01/22/2018. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 8002669 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. INVESTIGATION CONCLUSION: BASED ON THE EVALUATION PERFORMED THE DEFECT, AS NOTED BY THE END USER, CANNOT BE VERIFIED.

    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 THE PLUNGER ON A BD LUER-LOK¿ TIP SYRINGE PULLED OUT WHICH RESULTED IN LEAKAGE OF MEDICATION. THERE WAS NO REPORT OF MUCOUS MEMBRANE EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266445 BD LUER-LOK¿ TIP SYRINGE SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8002669 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 Other