BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II Y 24GAX0.75IN PRN/EC SLM

    MDR report key: 11311542 · Received February 10, 2021

    Report

    Report Number
    3006948883-2021-00219
    Event Type
    Malfunction
    Date Received
    February 10, 2021
    Date of Event
    January 4, 2021
    Report Date
    February 15, 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

    INVESTIGATION SUMMARY : A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8093410. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTIMA-II Y 24GAX0.75IN PRN/EC SLM LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) DUE TO THE NEED OF TREATMENT, THE NURSE PERFORMED AN INDWELLING NEEDLE PUNCTURE FOR THE CHILD. DURING THE PREPARATION, FLUID LEAKAGE WAS FOUND AT THE ADAPTER OF THE INDWELLING NEEDLE, SO THE NEEDLE WAS IMMEDIATELY REPLACED WITH ANOTHER SET OF INDWELLING NEEDLES AND THE PUNCTURE WAS CARRIED OUT AGAIN, WHICH DID NOT AFFECT THE CHILD.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTIMA-II Y 24GAX0.75IN PRN/EC SLM LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON JANUARY 4, DUE TO THE NEED OF TREATMENT, THE NURSE PERFORMED AN INDWELLING NEEDLE PUNCTURE FOR THE CHILD. DURING THE PREPARATION, FLUID LEAKAGE WAS FOUND AT THE ADAPTER OF THE INDWELLING NEEDLE, SO THE NEEDLE WAS IMMEDIATELY REPLACED WITH ANOTHER SET OF INDWELLING NEEDLES AND THE PUNCTURE WAS CARRIED OUT AGAIN, WHICH DID NOT AFFECT THE CHILD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206131 INTIMA-II Y 24GAX0.75IN PRN/EC SLM CATHETER FOZ BD (SUZHOU) 8093410

    Patients

    Seq Age Sex Outcome Treatment
    1