BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA II¿ IV CATHETER PRN ADAPTER

    MDR report key: 8160855 · Received December 13, 2018

    Report

    Report Number
    3006948883-2018-00306
    Event Type
    Malfunction
    Date Received
    December 13, 2018
    Date of Event
    November 26, 2018
    Report Date
    December 17, 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

    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 SECOND INSTANCE OF A DEFECTIVE 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. BASED ON THE SAMPLE SUBMITTED BY THE FACILITY, BD ENGINEERS WERE ABLE TO DETERMINE THAT THE MOST LIKELY ROOT CAUSE FOR THIS ISSUE IS AN ANOMALY IN THE FABRICATION PROCESS OF THE RAW MATERIAL USED FOR THE CATHETER TUBING. THE ABRASIVE MARKINGS FOUND ON THE DEVICE OCCUR SPORADICALLY DURING THE EXTRUDING PROCESS AND ARE CONTROLLED THROUGH VISUAL SORTING OF THE MATERIAL DURING RECEIPT FROM THE SUPPLIER. BD HAS NOTIFIED THE APPROPRIATE PERSONNEL. BD WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD INTIMA II IV CATHETER PRN ADAPTER THERE WAS LEAKAGE AT CATHETER DURING INFUSION.

    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 DURING USE OF THE BD INTIMA II¿ IV CATHETER PRN ADAPTER THERE WAS LEAKAGE AT CATHETER DURING INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998277 BD INTIMA II¿ IV CATHETER PRN ADAPTER INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 8141365

    Patients

    Seq Age Sex Outcome Treatment
    1 Other