BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II

    MDR report key: 19784755 · Received July 19, 2024

    Report

    Report Number
    3002601200-2024-00332
    Event Type
    Malfunction
    Date Received
    July 19, 2024
    Date of Event
    June 16, 2024
    Report Date
    August 6, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830787
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    IN RESPONSE TO THE EVENT REPORTED BY YOUR FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9050858. 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. ALTHOUGH THE PRESENCE OF FOREIGN MATTER WAS CONFIRMED, THE PHOTOGRAPH PROVIDED FOR THIS INCIDENT DID NOT PRESENT SUFFICIENT EVIDENCE TO IDENTIFY A DEFINITE ROOT CAUSE OF THE FOREIGN MATERIAL OR CONFIRM THE PRESENCE OF A DULL NEEDLE. IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS. UNFORTUNATELY 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 BD INTIMA-II HAD FOREIGN MATTER ON JUNE 16, 2024, WHEN THE NURSE INSERTED AN INTRAVENOUS CATHETER INTO THE PATIENT, SHE FOUND THAT THE NEEDLE WAS BLUNT AND THE HOSE WAS DIFFICULT TO PUSH, AND A WHITE UNKNOWN SUBSTANCE WAS ATTACHED TO THE NEEDLE CORE. THE SAME SITUATION OCCURRED IN ANOTHER CATHETER FROM THE SAME BATCH, CAUSING THE PATIENT TO HAVE REPEATED INDWELLING AND ARM PAIN. THE DEPARTMENT HAS SUSPENDED THE USE OF THIS BATCH OF CATHETERS AND REPORTED IT TO THE EQUIPMENT DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1552379 BD INTIMA-II INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 3353153 00382903830787

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown