BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8025008 · Received October 31, 2018

    Report

    Report Number
    3006948883-2018-00241
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Date of Event
    October 10, 2018
    Report Date
    November 26, 2018
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    30382903097037
    PMA / PMN Number
    K143610
    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 8107028. OUR RECORDS SHOW THE REPORTED LOT WAS MANUFACTURED IN APRIL OF 2018. 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 OF THE MACHINE TO BECOME MISALIGNED ALLOWING FOR THE RESULTING CRACK TO FORM IN THE DEVICE. THE ROOT CAUSE IS NOT CONFIRMED.

    Additional Manufacturer Narrative · 0

    THE CORRECTIONS ARE AS FOLLOWS: MEDICAL DEVICE BRAND NAME: BD INTIMA-II CLOSED IV CATHETER SYSTEM. MEDICAL DEVICE TYPE: FOZ. COMMON DEVICE NAME: INTRAVASCULAR CATHETER. UNIQUE IDENTIFIER (UDI) #: (B)(4). ADDITIONAL PMA/510(K)#: K143610. IT WAS REPORTED THAT A BD INTIMA-II CLOSED IV CATHETER SYSTEM HAD LEAKAGE AT THE CATHETER JUNCTION DURING EXHAUSTING. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY HAD LEAKAGE AT THE CATHETER JUNCTION DURING EXHAUSTING. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD INTIMA-II CLOSED IV CATHETER SYSTEM HAD LEAKAGE AT THE CATHETER JUNCTION DURING EXHAUSTING. 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 LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY HAD LEAKAGE AT THE CATHETER JUNCTION DURING EXHAUSTING. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862924 INTIMA II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 8107028 30382903097037

    Patients

    Seq Age Sex Outcome Treatment
    1 Other