BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRN ADAPTER

    MDR report key: 8897568 · Received August 15, 2019

    Report

    Report Number
    3006948883-2019-00654
    Event Type
    Malfunction
    Date Received
    August 15, 2019
    Date of Event
    July 22, 2019
    Report Date
    September 9, 2019
    Manufacturer
    BD (SUZHOU)
    Product Code
    FPA
    UDI-DI
    00382903886388
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8233030. 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. ALTHOUGH PHOTOS WERE SUBMITTED FOR EVALUATION, THEY DID NOT DISPLAY THE FAILURE MODE CLEARLY ENOUGH TO IDENTIFY THE ROOT CAUSE. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION, AND WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. H3 OTHER TEXT : SEE SECTION H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND BEFORE USE WITH A PRN ADAPTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT¿S NOTICED THAT YELLOW FOREIGN MATTER WAS EMBEDDED IN MALE LUER CONNECTION BEFORE UNWRAPPED THE PACKAGE DURING PRIMING."

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND BEFORE USE WITH A PRN ADAPTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT¿S NOTICED THAT YELLOW FOREIGN MATTER WAS EMBEDDED IN MALE LUER CONNECTION BEFORE UNWRAPPED THE PACKAGE DURING PRIMING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693662 PRN ADAPTER ADAPTER FPA BD (SUZHOU) 8233030 00382903886388

    Patients

    Seq Age Sex Outcome Treatment
    1 Other