BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ INJECTOR LUER LOCK

    MDR report key: 14193013 · Received April 25, 2022

    Report

    Report Number
    3003152976-2022-00166
    Event Type
    Malfunction
    Date Received
    April 25, 2022
    Date of Event
    March 31, 2022
    Report Date
    June 23, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    50382905150055
    PMA / PMN Number
    K132413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES. D9: RETURNED TO MANUFACTURER ON: 23-JUN-2022. H6: INVESTIGATION SUMMARY ONE INJECTOR AND SYRINGE ALONG WITH ONE CONNECTOR WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. AFTER VISUAL INSPECTION, NO ISSUES WERE OBSERVED WITH THE INJECTOR OR SYRINGE, HOWEVER, IT WAS OBSERVED THAT THE MEMBRANE WAS NOT PROPERLY ASSEMBLED ONTO THE CONNECTOR BODY, THEREFORE THE SYSTEM WAS OPEN AND LEAKED WHEN USED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR CONNECTOR LOT 2109219 AND INJECTOR LOT 2110001, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FIVE RETAINED SAMPLES OF CONNECTOR LOT 2109219 WERE USED FOR ADDITIONAL EVALUATION, NO DAMAGE OR DEFECTS WERE OBSERVED AND ALL MEMBRANES WERE VERIFIED TO BE PROPERLY ASSEMBLED. ASSEMBLY OF THE MEMBRANE IS PERFORMED MANUALLY. A DETECTION SYSTEM IS USED TO VERIFY THE PROPER WELDING AND LOCATION OF THE MEMBRANE. ALL QUALITY RECORDS VERIFY THE INSPECTIONS WERE PERFORMED ACCORDING TO PROCEDURE. WHILE WE CANNOT IDENTIFY A DIRECT ISSUE, IT WAS DETERMINED THIS INCIDENT IS DUE TO THE OPERATOR NOT PROPERLY WELDING THE MEMBRANE ONTO THE CONNECTOR BODY AND THE DETECTION SYSTEM ALSO NOT IDENTIFYING/REJECTING THE IMPACTED PIECE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PHASEAL¿ INJECTOR LUER LOCK LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " A LARGE AMOUNT OF THE ANTICANCER AGENT THEN LEAKED FROM AROUND THE INJECTION. "

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PHASEAL¿ INJECTOR LUER LOCK LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " A LARGE AMOUNT OF THE ANTICANCER AGENT THEN LEAKED FROM AROUND THE INJECTION. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982776 BD PHASEAL¿ INJECTOR LUER LOCK PHASEAL INJECTOR ONB BECTON DICKINSON, S.A. 515005 2109219 50382905150055

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown BD PHASEAL¿ INJECTOR LUER LOCK