BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II CLOSED IV CATHETER SYSTEM

    MDR report key: 10119385 · Received June 4, 2020

    Report

    Report Number
    3006948883-2020-00213
    Event Type
    Malfunction
    Date Received
    June 4, 2020
    Date of Event
    May 14, 2020
    Report Date
    June 22, 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

    H.6. INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9141583. 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 PHOTO WAS PROVIDED AND REVIEWED BUT A PHYSICAL 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 UNIT 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 H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MIXTURE OF BLOOD AND DRUGS LEAKED FROM THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM DURING THE HIGH-PRESSURE FILLING PROCESS AND "SOAKED" THE PATIENT'S SLEEVE. THIS OCCURRED ON 3 SEPARATE OCCASIONS, BUT THE DATES AND/OR PATIENT INFORMATION ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "THE 70-YEAR-OLD PATIENT UNDERWENT MRI IN HOSPITAL. THE TECHNICIAN TWISTED OFF THE HEPARIN CAP AND CONNECTED THE HIGH-PRESSURE FILLING CATHETER TO THE EXTENSION TUBE HOLDER. DURING THE HIGH-PRESSURE FILLING PROCESS, BLOOD LEAKAGE OCCURRED, AND THE BLOOD MIXTURE OF DRUGS LEAKED OUT AND SOAKED THE SLEEVE OF THE PATIENT. THIS WAS THE THIRD CASE OCCURRED IN THE DEPARTMENT, ONLY THE INTIMA-II PLUS WAS WITH NUCLEAR MAGNETIC EXAMINATION, THERE WAS A CERTAIN PROBABILITY OF BLEEDING OUT, THE PATIENT'S OPINION HAD VERY STRONG OPINION WITH THIS. THE REP HAD COLLECTED THE ISSUE PRODUCT, AND EXAMINED WITH THE SYRINGE. THE INDWELLING NEEDLE WAS IN GOOD CONDITION AND THERE WAS NO LEAKAGE. THERE WAS THE MISMATCHING QUESTION BETWEEN INTIMA-II PLUS AND SOME FACTORY'S HIGH VOLTAGE CONTRAST SYRINGE SCREW, SO IT CAUSED THE BLOOD LEAKAGE DURING ADDING PRESSURE."

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH: UNKNOWN. THE PATIENT¿S AGE WAS USED TO DETERMINE A PLACEHOLDER DATE. 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 A MIXTURE OF BLOOD AND DRUGS LEAKED FROM THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM DURING THE HIGH-PRESSURE FILLING PROCESS AND "SOAKED" THE PATIENT'S SLEEVE. THIS OCCURRED ON 3 SEPARATE OCCASIONS, BUT THE DATES AND/OR PATIENT INFORMATION ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE (B)(6) YEAR-OLD PATIENT UNDERWENT MRI IN HOSPITAL. THE TECHNICIAN TWISTED OFF THE HEPARIN CAP AND CONNECTED THE HIGH-PRESSURE FILLING CATHETER TO THE EXTENSION TUBE HOLDER. DURING THE HIGH-PRESSURE FILLING PROCESS, BLOOD LEAKAGE OCCURRED, AND THE BLOOD MIXTURE OF DRUGS LEAKED OUT AND SOAKED THE SLEEVE OF THE PATIENT. THIS WAS THE THIRD CASE OCCURRED IN THE DEPARTMENT, ONLY THE INTIMA-II PLUS WAS WITH NUCLEAR MAGNETIC EXAMINATION, THERE WAS A CERTAIN PROBABILITY OF BLEEDING OUT, THE PATIENT'S OPINION HAD VERY STRONG OPINION WITH THIS. THE REP HAD COLLECTED THE ISSUE PRODUCT, AND EXAMINED WITH THE SYRINGE. THE INDWELLING NEEDLE WAS IN GOOD CONDITION AND THERE WAS NO LEAKAGE. THERE WAS THE MISMATCHING QUESTION BETWEEN INTIMA-II PLUS AND SOME FACTORY'S HIGH VOLTAGE CONTRAST SYRINGE SCREW, SO IT CAUSED THE BLOOD LEAKAGE DURING ADDING PRESSURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585550 BD INTIMA-II CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 9141583

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other