BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 7097835 · Received December 7, 2017

    Report

    Report Number
    1213809-2017-00341
    Event Type
    Injury
    Date Received
    December 7, 2017
    Date of Event
    November 10, 2017
    Report Date
    February 14, 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
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: DHR REVIEW FOR BATCH 7030990 (P/N 305269): MANUFACTURING DATES: 01/28/2017 ¿ 02/7/2014. BATCH QUANTITY WAS (B)(4). ASSEMBLY BATCH 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. BATCH 7030990 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. SAMPLE EVALUATION: ONE LOOSE 3ML INTEGRA ASSEMBLED SYRINGE WAS RECEIVED BY BD CANAAN AND REPORTED TO BE FROM BATCH # 7030990 (P/N 305269). THE SAMPLE WAS VISUALLY EVALUATED. THE SYRINGE WAS FOUND TO HAVE BEEN ACTIVATED. THE NEEDLE HUB WAS REMOVED TO VERIFY THE NEEDLE CANNULA WAS CONTAINED INSIDE THE PLUNGER ROD AS DESIGNED. THE NEEDLE CANNULA WAS INDEED OBSERVED TO BE INSIDE THE PLUNGER ROD (RETRACTED). THE PRODUCT PERFORMED AS DESIGNED. BASED ON THE SAMPLE EVALUATION: UNCONFIRMED: BD CANAAN WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE. 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. CAPA IS NOT REQUIRED AS NO DEFECTS WERE CONFIRMED.

    Additional Manufacturer Narrative · 1

    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 BY A CONSUMER¿S SPOUSE THAT WHILE USING A BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE, THE NEEDLE BROKE OFF IN HER HUSBAND¿S SKIN DURING HIS INJECTION. THE CONSUMER¿S SPOUSE REPORTED HEARING A CLICK BUT THE NEEDLE WAS NOT THERE WHEN SHE REMOVED THE SYRINGE. THE CONSUMER WENT TO THE EMERGENCY ROOM AND HAD X-RAYS PERFORMED. THE NEEDLE WAS NOT FOUND. THE CONSUMER WAS ADVISED THAT THE NEEDLE HAD MOST LIKELY WORKED ITS WAY OUT PRIOR TO THE ER VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874984 BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE SAFETY ENGINEERED HYPODERMIC NEEDLE MEG BECTON DICKINSON MEDICAL SYSTEMS 7030990 30382903052692

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention