BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 9569580 · Received January 9, 2020

    Report

    Report Number
    3006948883-2019-01189
    Event Type
    Malfunction
    Date Received
    January 9, 2020
    Date of Event
    December 21, 2019
    Report Date
    February 19, 2020
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9170852. 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. UNFORTUNATELY A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING. WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRN WAS LOOSE AND LEAKAGE OCCURRED AND THEN SEPARATED FROM ADAPTER WITH A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM. THIS OCCURRED ON 3 SEPARATE OCCASIONS DURING USE, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: AFTER PUNCTURE, THE NURSE FOUND HEPARIN CAP WAS LEAKAGE AND COULD NOT BE TIGHTENED. THE HEPARIN CAP SEPARATED FROM THE CATHETER HUB, AND THERE WAS NO OBVIOUS CRACK ON THE SURFACE OF THE HEPARIN CAP. AT LEAST THREE CASES WERE FOUND IN THE SAME BATCH, AND NO SAMPLES WERE RETURNED.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: UNKNOWN. 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 PRN WAS LOOSE AND LEAKAGE OCCURRED AND THEN SEPARATED FROM ADAPTER WITH A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM. THIS OCCURRED ON 3 SEPARATE OCCASIONS DURING USE, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: AFTER PUNCTURE, THE NURSE FOUND HEPARIN CAP WAS LEAKAGE AND COULD NOT BE TIGHTENED. THE HEPARIN CAP SEPARATED FROM THE CATHETER HUB, AND THERE WAS NO OBVIOUS CRACK ON THE SURFACE OF THE HEPARIN CAP. AT LEAST THREE CASES WERE FOUND IN THE SAME BATCH, AND NO SAMPLES WERE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36005 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 9170852

    Patients

    Seq Age Sex Outcome Treatment
    1 Other