BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE INTEGRA 3ML LL

    MDR report key: 9695375 · Received February 11, 2020

    Report

    Report Number
    1213809-2020-00082
    Event Type
    Malfunction
    Date Received
    February 11, 2020
    Date of Event
    January 16, 2020
    Report Date
    March 16, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    00382903052837
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE LOOSE INTEGRA SYRINGE COVERED IN YELLOWISH FLUID INSIDE A BIOHAZARD BAG WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THE HUB WAS DISCONNECTED AND THE SPRING WAS LOOSE IN THE BAG. THE STOPPER WAS AT THE 0.1ML MARKING, WHICH IS THE EXPECTED LOCATION AFTER NORMAL RETRACTION. NO DEFECT WAS OBSERVED ON THE MANIPULATED SAMPLE. IT IS POSSIBLE THE HUB WAS NOT FULLY TIGHTENED ONTO THE SYRINGE. THE REPORTED DEFECT COULD NOT IDENTIFIED IN THE SAMPLE RECEIVED. THE SAMPLE WAS MANIPULATED AND COVERED IN UNKNOWN MEDICATION AND ONLY A LIMITED EVALUATION COULD BE PERFORMED. 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 THAT SYRINGE INTEGRA 3ML LL NEEDLE BROKE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FAULTY INTEGRA NEEDLE SYRINGE SYSTEM. THE RN WAS GIVING A THICK OILY BASED ANTIPSYCHOTIC MEDICATION, PARTWAY GIVING THE MEDICATION, NEEDLE WAS IN THE PATIENT SKIN, THE NEEDLE HEAD DETACHED FROM THE SYRINGE, ATTACHED ONLY BY THE SPRING AND THE NEEDLE LEFT DANGLING. STATED THEY HAD PREVIOUSLY HAS A SYRINGE LEAK FLUID AT THIS SPOT BUT DIDN'T REPORT IT OR DOCUMENT ANYWHERE.

    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 LL NEEDLE BROKE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FAULTY INTEGRA NEEDLE SYRINGE SYSTEM. THE RN WAS GIVING A THICK OILY BASED ANTIPSYCHOTIC MEDICATION, PARTWAY GIVING THE MEDICATION, NEEDLE WAS IN THE PATIENT SKIN, THE NEEDLE HEAD DETACHED FROM THE SYRINGE, ATTACHED ONLY BY THE SPRING AND THE NEEDLE LEFT DANGLING. STATED THEY HAD PREVIOUSLY HAS A SYRINGE LEAK FLUID AT THIS SPOT BUT DIDN'T REPORT IT OR DOCUMENT ANYWHERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160359 SYRINGE INTEGRA 3ML LL PISTON SYRINGE MEG BECTON DICKINSON MEDICAL SYSTEMS 7235634 00382903052837

    Patients

    Seq Age Sex Outcome Treatment
    1 Other