BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II Y 24GAX0.75IN SS PRN SLM NPVC

    MDR report key: 11773959 · Received May 4, 2021

    Report

    Report Number
    3006948883-2021-00476
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    April 7, 2021
    Report Date
    May 21, 2021
    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES, D.10. RETURNED TO MANUFACTURER ON: 4/19/2021. H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0140318. 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. ADDITIONALLY THE SAMPLES SUBMITTED BY THE FACILITY WERE VISUALIZED USING MICROSCOPY, WHICH ALLOWED OUR ENGINEERS TO IDENTIFY DAMAGE IN THE MIDDLE OF THE CATHETER TUBING. AFTER IDENTIFICATION A REVIEW OF THE MANUFACTURING LINE WAS CONDUCTED AND A POTENTIAL SOURCE WAS IDENTIFIED AS A CLAMPING CLAW IN THE AUTOMATED MANUFACTURING LINE. FURTHER INSPECTION OF THE CLAW INDICATES THAT THE DAMAGE WOULD ONLY BE SUSTAINED AS A RESULT OF WEAR ON THE SURFACE OF THE CLAW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTIMA-II Y 24GAX0.75IN SS PRN SLM NPVC TUBING RUPTURED DURING THE PUNCTURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "THE TUBE WAS RUPTURED DURING INDWELLING NEEDLE PUNCTURE" "IN THE PICTURE, A SMALL DROP OF WATER CAN BE SEEN IN THE MIDDLE OF THE CATHETER TUBING. THIS IS WHEN THE CUSTOMER IS FLUSHING, THE LIQUID SEEPS FROM THE MIDDLE OF THE CATHETER TUBING, FORMING SMALL WATER DROPLETS."

    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 INTIMA-II Y 24GAX0.75IN SS PRN SLM NPVC TUBING RUPTURED DURING THE PUNCTURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE TUBE WAS RUPTURED DURING INDWELLING NEEDLE PUNCTURE". "IN THE PICTURE, A SMALL DROP OF WATER CAN BE SEEN IN THE MIDDLE OF THE CATHETER TUBING. THIS IS WHEN THE CUSTOMER IS FLUSHING, THE LIQUID SEEPS FROM THE MIDDLE OF THE CATHETER TUBING, FORMING SMALL WATER DROPLETS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668617 INTIMA-II Y 24GAX0.75IN SS PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 0140318

    Patients

    Seq Age Sex Outcome Treatment
    1