BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II 24GAX0.75IN PRN SLM

    MDR report key: 11190597 · Received January 18, 2021

    Report

    Report Number
    3006948883-2021-00129
    Event Type
    Malfunction
    Date Received
    January 18, 2021
    Date of Event
    December 27, 2020
    Report Date
    March 1, 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 CORRECTED INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT INTIMA-II 24GAX0.75IN PRN SLM LEAKED BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS BLOOD ON THE NEEDLE DURING NEEDLE DISENGAGING. D.1. MEDICAL DEVICE BRAND NAME: INTIMA-II 24GAX0.75IN PRN SLM. D.4. MEDICAL DEVICE CATALOG #: 383028. D.4. MEDICAL DEVICE LOT #: 0231286. D.4. MEDICAL DEVICE EXPIRATION DATE: 9/21/2023. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). H.4. DEVICE MANUFACTURE DATE: 8/18/2020. H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT#. 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 THE REPORTED 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 24GAX0.75IN PRN SLM LEAKED BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS BLOOD ON THE NEEDLE DURING NEEDLE DISENGAGING.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE LOT #: THE CUSTOMER PROVIDED LOT # 0231286. THIS DOES NOT MATCH THE CATALOG NUMBER PROVIDED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTIMA-II Y 24GAX0.75IN PRN/EC SLM LEAKED BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS BLOOD ON THE NEEDLE DURING NEEDLE DISENGAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81116 INTIMA-II 24GAX0.75IN PRN SLM CATHETER FOZ BD (SUZHOU) 0231286

    Patients

    Seq Age Sex Outcome Treatment
    1