BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 15469721 · Received September 23, 2022

    Report

    Report Number
    3014704491-2022-00434
    Event Type
    Malfunction
    Date Received
    September 23, 2022
    Date of Event
    August 22, 2022
    Report Date
    September 15, 2022
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830282
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED, A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2082676. 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. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, VISUAL ANALYSIS WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RETAINED DEVICES WERE FOUND TO BE FREE OF ANY DAMAGE OR OTHER ABNORMALITIES. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. BD WILL CONTINUE TO MONITOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PIECE OF WHITE, PLASTIC FOREIGN MATTER WAS FOUND ON THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM TUBING WHEN REMOVING THE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "THE CHILD WAS ASKED TO INDWELL THE INTRAVENOUS INDWELLING NEEDLE BECAUSE OF THE UPPER RESPIRATORY TRACT INFECTION. WHEN THE SHIELD OF THE INDWELLING NEEDLE WAS PULLED OUT, A WHITE PLASTIC FOREIGN MATTER WAS FOUND IN THE CATHETER TUBING, AND THE INDWELLING NEEDLE WAS REPLACED AND RE-PUNCTURED, WHICH DID NOT AFFECT THE PATIENT." "THE SITUATION HAS BEEN VERIFIED WITH THE CUSTOMER: AFTER OPENING THE PACKAGE AND REMOVING THE NEEDLE CAP, A WHITE PLASTIC FOREIGN BODY WAS FOUND IN THE CATHETER, AND THE INDWELLING NEEDLE WAS REPLACED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565631 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2082676 00382903830282

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown