BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ L CONNECTOR C90J

    MDR report key: 15250906 · Received August 18, 2022

    Report

    Report Number
    3003152976-2022-00377
    Event Type
    Malfunction
    Date Received
    August 18, 2022
    Date of Event
    July 27, 2022
    Report Date
    September 13, 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

    COMMON DEVICE NAME: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM. 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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 2201207. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2025. D.10. DEVICE AVAILABLE FOR EVAL: YES. D.10. RETURNED TO MANUFACTURER ON: 12-SEP-2022. H.4. DEVICE MANUFACTURE DATE: 27-JAN-2022. H.6. INVESTIGATION SUMMARY: ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. AFTER VISUAL INSPECTION, IT WAS OBSERVED THAT THE MEMBRANE WAS NEVER ASSEMBLED ONTO THE CONNECTOR BODY. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2201207 NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. 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. A PROJECT WAS INITIATED TO FURTHER ADDRESS THIS ISSUE AND PREVENT ANY REOCCURRENCE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED FOR FUTURE OCCURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS SEPARATION AROUND THE MEMBRANE OF THE BD PHASEAL¿ L CONNECTOR C90J WHICH RESULTED IN LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A REPORT ABOUT SEPARATION OF THE MEMBRANE OF C90J, RESULTING IN LEAKAGE. THE HCP INSERTED C90J INTO A SALINE BAG AND INJECTED AN ANTICANCER DRUG. THE HCP THEN DISENGAGED THE INJECTOR, AND FOUND THAT THE MEMBRANE OF THE C90J WAS SEPARATED, RESULTING IN LEAKAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS SEPARATION AROUND THE MEMBRANE OF THE BD PHASEAL¿ L CONNECTOR C90J WHICH RESULTED IN LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A REPORT ABOUT SEPARATION OF THE MEMBRANE OF C90J, RESULTING IN LEAKAGE. THE HCP INSERTED C90J INTO A SALINE BAG AND INJECTED AN ANTICANCER DRUG. THE HCP THEN DISENGAGED THE INJECTOR, AND FOUND THAT THE MEMBRANE OF THE C90J WAS SEPARATED, RESULTING IN LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2460302 BD PHASEAL¿ L CONNECTOR C90J SEE H.10. ONB BECTON DICKINSON, S.A. 2201207

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown