BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE INTEGRA 3ML W/NDL 23X1 RB

    MDR report key: 12393660 · Received August 31, 2021

    Report

    Report Number
    1213809-2021-00605
    Event Type
    Malfunction
    Date Received
    August 31, 2021
    Date of Event
    August 1, 2021
    Report Date
    September 16, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    00382903052714
    PMA / PMN Number
    K011103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: EIGHT 3ML INTEGRA SYRINGES WITH NEEDLE (P/N 305271) SEALED IN BLISTERPAKS FROM BATCH #0002375 WERE RECEIVED. THE SAMPLES WERE VISUALLY EVALUATED AND TESTED FOR SHIELD REMOVAL FORCE. NO SAMPLES DISPLAYED ANY VISUAL DEFECTS. TWO OF THE EIGHT SAMPLES SHIELDS HAD FALLEN OFF INSIDE OF THE BLISTERPAK POSSIBLY DUE TO SHIPMENT CONDITIONS OR OTHER HANDLING AND WERE NOT TESTED. SIX SAMPLES THAT WERE TESTED FOR SHIELD REMOVAL FORCE ALL YIELDED ACCEPTABLE RESULTS PER PRODUCT SPECIFICATION. SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED AND CORRECTIVE ACTIONS ARE NOT NECESSARY. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE INTEGRA 3ML W/NDL 23X1 RB NEEDLE HUB SEPARATED. THIS OCCURRED ON 4 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT NEEDLE SHIELD IS DIFFICULT TO REMOVE. IT WAS ALSO REPORTED THE NEEDLE HUB SEPARATED. VERBATIM: CONSUMER REPORTED NEEDLE SHIELD DIFFICULT TO REMOVE. CONSUMER ALSO REPORTED NEEDLE HUB SEPARATED. CONSUMER STATED THAT THERE ARE 4 SYRINGES IN TOTAL WITH THE ISSUE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE INTEGRA 3ML W/NDL 23X1 RB NEEDLE HUB SEPARATED. THIS OCCURRED ON 4 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT NEEDLE SHIELD IS DIFFICULT TO REMOVE. IT WAS ALSO REPORTED THE NEEDLE HUB SEPARATED. VERBATIM: CONSUMER REPORTED NEEDLE SHIELD DIFFICULT TO REMOVE. CONSUMER ALSO REPORTED NEEDLE HUB SEPARATED. CONSUMER STATED THAT THERE ARE 4 SYRINGES IN TOTAL WITH THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1295607 SYRINGE INTEGRA 3ML W/NDL 23X1 RB PISTON SYRINGE MEG BECTON DICKINSON MEDICAL SYSTEMS 0002375 00382903052714

    Patients

    Seq Age Sex Outcome Treatment
    1