BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 8020329 · Received October 30, 2018

    Report

    Report Number
    1213809-2018-00719
    Event Type
    Malfunction
    Date Received
    October 30, 2018
    Date of Event
    October 11, 2018
    Report Date
    December 19, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903052715
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    56 SEALED AND 2 OPENED PACKAGED INTEGRA SYRINGES WERE RECEIVED FROM THE COMPLAINT BATCH #6299514 (P/N 305271). IN ADDITION TO THE COMPLAINT BATCH, 1 SEALED PACKAGE WAS RECEIVED FROM BATCH #7001878, 2 PACKAGES FROM BATCH #4202867, 1 PACKAGE FROM BATCH #4202868, 1 PACKAGE FROM BATCH 4274640 AND 1 PACKAGE FROM BATCH #4133889. THE SAMPLES WERE VISUALLY EVALUATED. NO VISUAL DEFECTS WERE OBSERVED. THE 2 OPENED PACKAGES WERE ASSUMED TO HAVE BEEN USED AND CONTAMINATED AND WERE NOT FURTHER EVALUATED. ALL OF THE SEALED PACKAGES HAD THEIR PLUNGER FUNCTION EVALUATED. ALL PLUNGERS MOVED SMOOTHLY AS DESIGNED WITH NO ISSUES, SUCH AS STICKINESS OR OTHERWISE, NOTED. ALL OF THESE SAMPLES HAD THE NEEDLE RETRACTION TESTED. ALL NEEDLES RETRACTED AS DESIGNED WITH NO ISSUES OBSERVED. THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE SAMPLES RECEIVED. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD INTEGRA SYRINGE WITH DETACHABLE NEEDLE THERE WAS AN ISSUE WITH DIFFICULT PLUNGER MOVEMENT. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    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 WITH THE USE OF THE BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE THERE WAS AN ISSUE WITH DIFFICULT PLUNGER MOVEMENT. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861493 BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE PISTON SYRINGE MEG BECTON DICKINSON MEDICAL SYSTEMS 6299514 30382903052715

    Patients

    Seq Age Sex Outcome Treatment
    1 Other