BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 7907109 · Received September 25, 2018

    Report

    Report Number
    1213809-2018-00643
    Event Type
    Malfunction
    Date Received
    September 25, 2018
    Date of Event
    September 4, 2018
    Report Date
    November 27, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903052722
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIX SEALED PACKAGED 3ML INTEGRA SYRINGES WITH NEEDLE WERE RECEIVED AND CONFIRMED TO BE FROM BATCH #4024047 AND 7177699 (P/N 305272). THE SYRINGES WERE REMOVED FROM THE PACKAGES AND VISUALLY EVALUATED. NO MANUFACTURING DEFECTS WERE OBSERVED. WATER WAS DRAWN INTO ONE OF THE SYRINGES TO TEST. A FEW AIR BUBBLES WERE INSIDE THE WATER AS IS NORMAL. AIR BUBBLE REMOVING TECHNIQUES, SUCH AS BARREL TAPPING, WERE USED TO RID THE LIQUID FROM THE BUBBLES. NO DEFECTS WERE OBSERVED DURING THE TEST. THE SAME EXPERIMENT WAS PERFORMED WITH A STANDARD 3ML SYRINGE WITH NON-RETRACTABLE NEEDLE FOR COMPARISON. SIMILAR RESULTS WERE OBSERVED WITH A FEW AIR BUBBLES INSIDE THE LIQUID AND BUBBLE REMOVING TECHNIQUES HAD TO BE USED TO RID THE LIQUID FROM THEM. THE SYRINGES FUNCTIONED AS EXPECTED. NO DEFECTS COULD BE CONFIRMED. ROOT CAUSE NOT DEFINED SINCE DEFECTS WERE NOT CONFIRMED IN SAMPLES RECEIVED. NO CORRECTIVE ACTIONS RECOMMENDED SINCE PRODUCT DEFECT WAS NOT CONFIRMED. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE TWO 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 THAT THE CONSUMER WAS NOT ABLE TO EXPEL THE AIR BUBBLES AND AFTER USE THE MEDICATION WOULD LEAK OUT WITH THE USE OF THE BD INTEGRA SYRINGE WITH DETACHABLE NEEDLE. 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. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONSUMER WAS NOT ABLE TO EXPEL THE AIR BUBBLES AND AFTER USE THE MEDICATION WOULD LEAK OUT WITH THE USE OF THE BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746016 BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE PISTON SYRINGE MEG BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 30382903052722

    Patients

    Seq Age Sex Outcome Treatment
    1 Other