BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8034947 · Received November 2, 2018

    Report

    Report Number
    3006948883-2018-00246
    Event Type
    Malfunction
    Date Received
    November 2, 2018
    Date of Event
    October 13, 2018
    Report Date
    November 26, 2018
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830336
    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 8141417. OUR RECORDS SHOW THE REPORTED LOT WAS MANUFACTURED IN (B)(6) OF 2018, AND DETERMINED THAT THIS IS THE ONLY INSTANCE OF A DAMAGED ADAPTER 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. ADDITIONALLY, A SAMPLE WAS RECEIVED FOR THE PURPOSE OF OUR INVESTIGATION. THE INVESTIGATORS WERE ABLE TO OBSERVE THE REPORTED FAILURE MODE IN THE SAMPLE PROVIDED A SMALL CRACKED WAS FOUND DURING LEAKAGE TESTING AND WAS LOCATED ON THE ADAPTER. THE RETURNED PRODUCT'S PARAMETERS FOR SWAGE DIMENSION AND SWAGE LENGTH WERE TESTED AND FOUND TO BE WITHIN PRODUCT SPECIFICATIONS. HOWEVER, DEPENDING ON PRESSURE VARIANCE IN THE AUTO LINE'S SWAGE PRESSURE IT IS POSSIBLE FOR THE MACHINE TO BECOME MISALIGNED ALLOWING FOR THE RESULTING CRACK TO FORM IN THE DEVICE. THE PLANT HAS INVESTIGATED THIS DEFECT OF CATHETER ADAPER CRACK, BUT THE ROOT CAUSE HAS NOT BEEN IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD INTIMA-II CLOSED IV CATHETER SYSTEM LEAKED BLOOD AT THE SEPTUM ADAPTER DUE TO A SMALL CRACK. THERE WAS NO REPORT OF EXPOSURE, SERIOUS 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 THAT A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM LEAKED BLOOD AT THE SEPTUM ADAPTER DUE TO A SMALL CRACK. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875472 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER FOZ BD (SUZHOU) 8141417 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 Other