BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II CLOSED IV CATHETER SYSTEM

    MDR report key: 10351176 · Received July 31, 2020

    Report

    Report Number
    3006948883-2020-00323
    Event Type
    Malfunction
    Date Received
    July 31, 2020
    Date of Event
    June 22, 2020
    Report Date
    August 12, 2020
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9141672. 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 FOREIGN MATERIAL. 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 PRIOR TO USE FOREIGN MATTER WAS DISCOVERED ON CAP OF NEEDLE WITH A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE PATIENT WAS PREPARING FOR BEDSIDE INFUSION ON (B)(6) 2020 AFTER OPENING THE OUTER PACKAGE OF THE INDWELLING NEEDLE, IT WAS FOUND THAT THERE WAS BLACK UNKNOWN MATTER ATTACHED TO THE CAP OF THE INDWELLING NEEDLE, THE INDWELLING NEEDLE WAS IMMEDIATELY REPLACED, THE RELEVANT DEPARTMENTS WERE NOTIFIED, AND INSPECTION WAS FOUND IN TIME. THE PATIENT WAS NOT AFFECTED YET.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE FOREIGN MATTER WAS DISCOVERED ON CAP OF NEEDLE WITH A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE PATIENT WAS PREPARING FOR BEDSIDE INFUSION ON (B)(6) 2020, AFTER OPENING THE OUTER PACKAGE OF THE INDWELLING NEEDLE, IT WAS FOUND THAT THERE WAS BLACK UNKNOWN MATTER ATTACHED TO THE CAP OF THE INDWELLING NEEDLE, THE INDWELLING NEEDLE WAS IMMEDIATELY REPLACED, THE RELEVANT DEPARTMENTS WERE NOTIFIED, AND INSPECTION WAS FOUND IN TIME. THE PATIENT WAS NOT AFFECTED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817412 BD INTIMA-II CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 9141672

    Patients

    Seq Age Sex Outcome Treatment
    1 Other