BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ L CONNECTOR C90J

    MDR report key: 15704923 · Received October 31, 2022

    Report

    Report Number
    3003152976-2022-00489
    Event Type
    Malfunction
    Date Received
    October 31, 2022
    Date of Event
    October 6, 2022
    Report Date
    December 15, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 2202204. D4: MEDICAL DEVICE EXPIRATION DATE: 21-JAN-2026. H4: DEVICE MANUFACTURE DATE: 10-JUN-2022. H6: INVESTIGATION SUMMARY: ONE SAMPLE AND MULTIPLE PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. AFTER VISUAL INSPECTION, IT WAS OBSERVED THAT THE MEMBRANE WAS MISSING AND NEVER ASSEMBLED ONTO THE CONNECTOR BODY, THEREFORE THE SYSTEM WAS OPEN AND LEAKED WHEN USED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2202204, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. AS THE SECOND SUSPECTED LOT PROVIDED IS NOT VALID, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. 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 WELDING THE MEMBRANE ONTO THE CONNECTOR BODY AND THE DETECTION SYSTEM ALSO NOT IDENTIFYING/REJECTING THE IMPACTED PIECE. ADDITIONAL TRAINING WILL BE PERFORMED WITH PERSONNEL TO REINFORCE THE PROPER PROCESS. A PROJECT WAS INITIATED TO FURTHER ADDRESS THIS ISSUE AND PREVENT ANY REOCCURRENCE. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ L CONNECTOR C90J SEPERATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: WHEN THE HCP DISENGAGED THE INJECTOR ENGAGED TO L CONNECTOR CONNECTED TO SALINE, THE MEMBRANE WAS SEPARATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ L CONNECTOR C90J SEPERATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: WHEN THE HCP DISENGAGED THE INJECTOR ENGAGED TO L CONNECTOR CONNECTED TO SALINE, THE MEMBRANE WAS SEPARATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482881 BD PHASEAL¿ L CONNECTOR C90J INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown