BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II 20GAX1.16IN PRN SLM NPVC

    MDR report key: 9117518 · Received September 25, 2019

    Report

    Report Number
    3006948883-2019-00799
    Event Type
    Malfunction
    Date Received
    September 25, 2019
    Date of Event
    September 10, 2019
    Report Date
    October 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

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9141586. 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, A SAMPLE WAS SUBMITTED FOR EVALUATION; VISUAL OBSERVATION OF THE DEVICE DETERMINED THAT IT WAS NORMAL AND WITHIN PRODUCT SPECIFICATION. UNFORTUNATELY, WITHOUT THE ABILITY TO OBSERVE THE REPORTED NONCONFORMANCE BD WAS UNABLE TO DETERMINE A ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTIMA-II 20GAX1.16IN PRN SLM NPVC NEEDLE TIP WAS "BLACK" AND OBSERVED BEFORE PUNCTURING THE PATIENT. THIS OCCURRED ON 150 SEPARATE OCCASIONS, BUT THE DATES AND/OR PATIENT INFORMATION ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "WHEN THE NURSE PREPARED TO PUNCTURE THE PATIENT, SHE FOUND THAT THE TIP OF THE NEEDLE WAS BLACK."

    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 20GAX1.16IN PRN SLM NPVC NEEDLE TIP WAS "BLACK" AND OBSERVED BEFORE PUNCTURING THE PATIENT. THIS OCCURRED ON 150 SEPARATE OCCASIONS, BUT THE DATES AND/OR PATIENT INFORMATION ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "WHEN THE NURSE PREPARED TO PUNCTURE THE PATIENT, SHE FOUND THAT THE TIP OF THE NEEDLE WAS BLACK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915394 INTIMA-II 20GAX1.16IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 9141586

    Patients

    Seq Age Sex Outcome Treatment
    1 Other