BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 12194052 · Received July 19, 2021

    Report

    Report Number
    3006948883-2021-00811
    Event Type
    Malfunction
    Date Received
    July 19, 2021
    Date of Event
    April 19, 2021
    Report Date
    July 22, 2021
    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

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1021276. 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, 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM LEAKED FROM THE END OF THE NEEDLE TUBE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE PATIENT COMPLAINED OF "PERSISTENT HEART PALPITATIONS AND CHEST TIGHTNESS FOR 2 HOURS". THE DIAGNOSIS WAS HEART FAILURE. THE PATIENT WAS GIVEN INTRAVENOUS INFUSION AT (B)(6), AND THE PATIENT WAS SEALED. AFTER PUNCTURING WITH AN INDWELLING NEEDLE, IT IS FOUND THAT THE END OF THE NEEDLE TUBE IS LEAKING. AFTER THE PATIENT IS REPLACED WITH THE INDWELLING NEEDLE, THE PATIENT IS RE-PUNCTURED AND THEN PUNCTURED WITH A NORMAL INFUSION, CAUSING SECONDARY PAIN TO THE PATIENT, INCREASING THE COST OF DEPARTMENT CONSUMABLES AND INCREASING THE WORKLOAD OF NURSES.

    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 THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM LEAKED FROM THE END OF THE NEEDLE TUBE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE PATIENT COMPLAINED OF "PERSISTENT HEART PALPITATIONS AND CHEST TIGHTNESS FOR 2 HOURS". THE DIAGNOSIS WAS HEART FAILURE. THE PATIENT WAS GIVEN INTRAVENOUS INFUSION AT 08:20 ON APRIL 19, AND THE PATIENT WAS SEALED. AFTER PUNCTURING WITH AN INDWELLING NEEDLE, IT IS FOUND THAT THE END OF THE NEEDLE TUBE IS LEAKING. AFTER THE PATIENT IS REPLACED WITH THE INDWELLING NEEDLE, THE PATIENT IS RE-PUNCTURED AND THEN PUNCTURED WITH A NORMAL INFUSION, CAUSING SECONDARY PAIN TO THE PATIENT, INCREASING THE COST OF DEPARTMENT CONSUMABLES AND INCREASING THE WORKLOAD OF NURSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089080 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ 1021276

    Patients

    Seq Age Sex Outcome Treatment
    1