BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTEGRA¿ SYRINGE WITH NEEDLE

    MDR report key: 7060313 · Received November 27, 2017

    Report

    Report Number
    1213809-2017-00275
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    October 24, 2017
    Report Date
    May 21, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903052692
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DHR REVIEW FOR BATCH 6201980 (P/N (B)(4)): MANUFACTURING DATES: 08/14/2016 TO 08/17/2016. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 6201980 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. CAPA IS NOT REQUIRED AS NO DEFECTS WERE CONFIRMED. 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. .

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: SEVEN LOOSE 3ML INTEGRA ASSEMBLED SYRINGES WITH NEEDLE WERE RECEIVED BY BD CANAAN AND REPORTED TO BE FROM BATCH #6201980 (P/N 305269). THE SAMPLES WERE VISUALLY EVALUATED. THE SYRINGES WERE TAPED TO THE NEEDLE SHIELD. THE SYRINGES WERE NOT ACTIVATED WITH THE PLUNGER THUMBREST LOCATED ABOVE THE BARREL SHROUD OF ALL RETURNED SYRINGES. THE TAPE AND NEEDLE SHIELDS WERE REMOVED TO EVALUATE THE CANNULA. TWO SYRINGES WERE FOUND TO HAVE THE NEEDLE CANNULA LOOSE IN THE NEEDLE SHIELD. A NEEDLE SEPARATING FROM HUB IS A REJECTABLE CONDITION. A NEEDLE CANNULA BEING SEPARATED FROM THE NEEDLE HUB IS A REJECTABLE CONDITION AT BD CANAAN. THREE SYRINGES WERE FOUND TO HAVE CRACKED BARRELS. TWO OF THESE SYRINGES WERE CRACKED FROM JUST BELOW THE BD LOGO TO APPROXIMATELY THE 1 1/2 ML LINE. ONE SYRINGE HAD MULTIPLE LINEAR CRACKS RUNNING FROM THE 2ML TO THE 1ML GRAD LINE. A CRACKED BARREL IS A REJECTABLE CONDITION. DHR REVIEW FOR BATCH 6201980 (P/N 305269): MANUFACTURING DATES: 08/14/2016 TO 08/17/2016. BATCH QUANTITY WAS 255,000. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 6201980 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. BASED ON THE SAMPLE EVALUATION: CONFIRMED: BD CANAAN WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE. ROOT CAUSE WAS NOT DETERMINED.

    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 AFTER USE OF THE BD INTEGRA 3 ML SYRINGE WITH DETACHABLE NEEDLE THE CONSUMER REPORTED THAT THE SYRINGE NEEDLE BROKE OFF INTO HIS THIGH AFTER HIS INJECTION. CONSUMER REMOVED THE NEEDLES FROM HIS THIGH WITHOUT MEDICAL ASSISTANCE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839021 BD INTEGRA¿ SYRINGE WITH NEEDLE SAFETY SYRINGE W/NEEDLE MEG BECTON DICKINSON MEDICAL SYSTEMS 6201980 30382903052692

    Patients

    Seq Age Sex Outcome Treatment
    1 Other