BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ PRN ADAPTER

    MDR report key: 9786744 · Received March 4, 2020

    Report

    Report Number
    3006948883-2020-00074
    Event Type
    Malfunction
    Date Received
    March 4, 2020
    Date of Event
    February 12, 2020
    Report Date
    April 28, 2020
    Manufacturer
    BD (SUZHOU)
    Product Code
    FPA
    PMA / PMN Number
    K933467
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO CORRECTED INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: NO. H.6. INVESTIGATION: UNFORTUNATELY A LOT NUMBER COULD NOT BE SUBMITTED FOR THIS COMPLAINT, AND COULD NOT BE DETERMINED FROM THE PHOTOGRAPHS PROVIDED. PREVENTING OUR INVESTIGATION TEAM FROM CONDUCTING A DEVICE HISTORY REVIEW. DUE TO CURRENT PRACTICES BEING IMPLEMENTED BY CHINESE CUSTOMS USED MEDICAL DEVICE CANNOT BE SUBMITTED TO THE MANUFACTURING FACILITY FOR FUNCTIONAL TESTING. PHOTOGRAPHS OF THE DEVICES WERE SUBMITTED; OUR EVALUATION OF THE PHOTOGRAPHS FOUND THE DEVICE TO BE FREE OF ANY DEFECT, DEFORMITIES, OR OTHER NON CONFORMANCES. WITHOUT THE ABILITY TO TEST THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. CAPA#1474444 WAS INITIATED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DRUG LEAKED FROM THE BD¿ PRN ADAPTER AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "DRUG LEAKED AFTER USED. HCP REMOVED THE DEVICE TOGETHER WITH THE CATHETER."

    Additional Manufacturer Narrative · 1

    MEDICAL 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DRUG LEAKED FROM THE BD¿ PRN ADAPTER AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "DRUG LEAKED AFTER USED. HCP REMOVED THE DEVICE TOGETHER WITH THE CATHETER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253298 BD¿ PRN ADAPTER INTRAVASCULAR CATHETER FPA BD (SUZHOU) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other