BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ Y 22GAX1.00IN CATHETER

    MDR report key: 13100157 · Received December 28, 2021

    Report

    Report Number
    3014704491-2021-00397
    Event Type
    Malfunction
    Date Received
    December 28, 2021
    Date of Event
    November 27, 2021
    Report Date
    February 8, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1111451. 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 ANY DAMAGE OR OTHER ABNORMALITIES. 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 PRIOR TO INJECTION WITH A BD INTIMA-II¿ Y 22GAX1.00IN CATHETER FOREIGN MATTER WAS DISCOVERED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THERE WAS HAIR SCALE AT THE FRONT PART OF INDWELLING NEEDLE BEFORE INJECTION, AND THE INDWELLING NEEDLE WAS REPLACED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO INJECTION WITH A BD INTIMA-II¿ Y 22GAX1.00IN CATHETER FOREIGN MATTER WAS DISCOVERED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THERE WAS HAIR SCALE AT THE FRONT PART OF INDWELLING NEEDLE BEFORE INJECTION, AND THE INDWELLING NEEDLE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1999172 BD INTIMA-II¿ Y 22GAX1.00IN CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 1111451

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown