BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II Y 22GAX0.75IN PRN/EC SLM

    MDR report key: 8839221 · Received July 29, 2019

    Report

    Report Number
    3006948883-2019-00604
    Event Type
    Malfunction
    Date Received
    July 29, 2019
    Date of Event
    July 8, 2019
    Report Date
    August 28, 2019
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: IT'S NOTICED THAT BLOOD LEAKAGE AT PRN AFTER COMPLETED PENETRATION LOT# 9023837. MASTER PRODUCTION RECORDS WERE REVIEWED FOR THE LOT NUMBER AND NO NON-CONFORMANCES WERE NOTED DURING THE MANUFACTURING OF THIS LOT. OUR RECORDS INDICATE THAT THE REVIEWED BATCH RECORD PASSED ALL THE IN-PROCESS INSPECTION. A VISUAL INSPECTION OF THE RETAINED SAMPLES WAS PERFORMED, AND NO DEFECTS WERE NOTED. ONLY THIS COMPLAINT HAS BEEN RECEIVED FOR THE REPORTED DEFECT AND LOT NUMBER A PHOTO OR SAMPLE WAS NOT PROVIDED BY THE FACILITY. AT THIS TIME, BD COULD NOT OBSERVE THE FAILURE MODE OR DETERMINE A POSSIBLE ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE INTIMA-II Y 22GAX0.75IN PRN/EC SLM AFTER SUCCESSFUL PUNCTURE AND INDWELLING IT WAS NOTICED THAT THE CONNECTION BETWEEN THE HEPARIN CAP AND THE INDWELLING NEEDLE WAS NOT TIGHTLY CONNECTED AND BLOOD LEAKAGE OCCURRED. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: IT'S NOTICED THAT BLOOD LEAKAGE AT PRN AFTER COMPLETED PENETRATION LOT# 9023837.

    Additional Manufacturer Narrative · 1

    BATCH 9023837 DOES NOT EXIST FOR MATERIAL 383026. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE INTIMA-II Y 22GAX0.75IN PRN/EC SLM AFTER SUCCESSFUL PUNCTURE AND INDWELLING IT WAS NOTICED THAT THE CONNECTION BETWEEN THE HEPARIN CAP AND THE INDWELLING NEEDLE WAS NOT TIGHTLY CONNECTED AND BLOOD LEAKAGE OCCURRED. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: IT'S NOTICED THAT BLOOD LEAKAGE AT PRN AFTER COMPLETED PENETRATION LOT# 9023837.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632414 INTIMA-II Y 22GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other