BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA II¿ IV CATHETER PRN ADAPTER

    MDR report key: 8039192 · Received November 5, 2018

    Report

    Report Number
    3006948883-2018-00247
    Event Type
    Malfunction
    Date Received
    November 5, 2018
    Date of Event
    October 17, 2018
    Report Date
    November 19, 2018
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8141365. OUR RECORDS SHOW THE REPORTED LOT WAS MANUFACTURED IN JULY OF 2018, AND DETERMINED THAT THIS IS THE ONLY INSTANCE OF A DAMAGED CATHETER 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 OF PACKAGED GOODS. ALTHOUGH, A PHOTOGRAPH WAS SUBMITTED FOR EVALUATION, OUR INVESTIGATORS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS EVENT WITHOUT THE ABILITY TO REVIEW THE AFFECTED SAMPLE.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD INTIMA II¿ IV CATHETER PRN ADAPTER THERE WAS AN ISSUE WITH LEAKAGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    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 WITH THE USE OF THE BD INTIMA II¿ IV CATHETER PRN ADAPTER THERE WAS AN ISSUE WITH LEAKAGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876881 BD INTIMA II¿ IV CATHETER PRN ADAPTER INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 8141365

    Patients

    Seq Age Sex Outcome Treatment
    1 Other