BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRN ADAPTOR

    MDR report key: 17028253 · Received May 30, 2023

    Report

    Report Number
    3014704491-2023-00221
    Event Type
    Malfunction
    Date Received
    May 30, 2023
    Date of Event
    March 1, 2023
    Report Date
    June 1, 2023
    Manufacturer
    BD (SUZHOU)
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2049555. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PRN ADAPTOR EXPERIENCED A CRACK CAUSING LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE LEAKAGE WAS FOUND DURING INFUSION, AND THE NURSE WAS NOTIFIED. AFTER CHECKING, THE CRACK OF THE HEPARIN CAP WAS FOUND, AND THE NURSE IMMEDIATELY REPLACED IT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PRN ADAPTOR EXPERIENCED A CRACK CAUSING LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE LEAKAGE WAS FOUND DURING INFUSION, AND THE NURSE WAS NOTIFIED. AFTER CHECKING, THE CRACK OF THE HEPARIN CAP WAS FOUND, AND THE NURSE IMMEDIATELY REPLACED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131668 BD PRN ADAPTOR INTRAVASCULAR ADMINISTRATION SET FPA BD (SUZHOU) 2049555

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown