BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTOR LUER LOCK N35J

    MDR report key: 10394377 · Received August 11, 2020

    Report

    Report Number
    3003152976-2020-00355
    Event Type
    Malfunction
    Date Received
    August 11, 2020
    Date of Event
    July 17, 2020
    Report Date
    October 20, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE INJECTOR CONNECTED TO A SYRINGE ALONG WITH A PRIMING SET WAS RETURNED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE OR DEFECTS WERE OBSERVED ON THE INJECTOR, INJECTOR MEMBRANE, OR THE MEMBRANE OF THE CONNECTOR WHICH IS ADHERED ONTO THE INFUSION SET. LEAKAGE TESTING WAS PERFORMED AND NO LEAKS WERE IDENTIFIED. ADDITIONALLY, A PRESSURE TEST WAS CONDUCTED ON THE USED SAMPLES, NO LEAK WAS OBSERVED FROM THE INJECTOR MEMBRANE, HOWEVER, A LEAK DID OCCUR BETWEEN THE CONNECTION OF THE INJECTOR AND CONNECTOR OF THE INFUSION SET. IT WAS ALSO NOTED THAT BOTH MEMBRANES OF THE CONNECTOR AND INJECTOR APPEARED TO HAVE BEEN PENETRATED MULTIPLE TIMES. DURING MANUFACTURING, LEAKAGE AND POSITIVE PRESSURE TESTING IS PERFORMED TO VERIFY THE SEALING QUALITY OF THE MEMBRANE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2001105, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TWO RETAINED SAMPLES OF THE REPORTED LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE OR DEFECTS WAS OBSERVED ON THE INJECTOR OR ANY OF THE INJECTOR COMPONENTS. FUNCTIONAL TESTING WAS PERFORMED, CONNECTING THE INJECTOR TO A SAMPLE SYRINGE, PROTECTOR AND VIAL ACCORDING TO THE INSTRUCTIONS FOR USE. IN ALL CASES THE PRODUCT FUNCTIONED PROPERLY, AND NO LEAKAGES WERE OBSERVED. DURING MANUFACTURING, LEAKAGE AND POSITIVE PRESSURE TESTING IS PERFORMED TO VERIFY THE SEALING QUALITY OF THE MEMBRANE. TESTING WAS REVIEWED FOR LOT 2001105, ALL RESULTS WERE FOUND TO BE WITHIN SPECIFICATION. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME. THE PERFORMANCE OF THE SEALING MEMBRANE IS REDUCED AFTER MULTIPLE PERFORATIONS AND EXTENDED ACTIVATION TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INJECTOR LUER LOCK N35J LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING PREPARATION OF CARBOPLATIN, WHEN INJECTING THE SOLUTION FROM A SYRINGE INTO THE PRIMING SET, LEAKAGE OCCURRED AT THE N35J AREA. THE EXACT LOCATION OF LEAKAGE REMAINS UNKNOWN. THE CUSTOMER IS ASKING FOR INVESTIGATION ON THE ACTUAL SAMPLE".

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INJECTOR LUER LOCK N35J LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING PREPARATION OF CARBOPLATIN, WHEN INJECTING THE SOLUTION FROM A SYRINGE INTO THE PRIMING SET, LEAKAGE OCCURRED AT THE N35J AREA. THE EXACT LOCATION OF LEAKAGE REMAINS UNKNOWN. THE CUSTOMER IS ASKING FOR INVESTIGATION ON THE ACTUAL SAMPLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858650 INJECTOR LUER LOCK N35J PHASEAL -INJECTOR ONB BECTON DICKINSON, S.A. 2001105

    Patients

    Seq Age Sex Outcome Treatment
    1 Other