BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM

    MDR report key: 10241783 · Received July 7, 2020

    Report

    Report Number
    9610847-2020-00201
    Event Type
    Injury
    Date Received
    July 7, 2020
    Date of Event
    June 15, 2020
    Report Date
    July 21, 2020
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    30382903833123
    PMA / PMN Number
    K013800
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 9031833. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT AND ALL INSPECTIONS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, TWO PICTURE SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM; HOWEVER, THROUGH EXAMINATION OF THE PICTURE SAMPLES ALONE, THE REPORTED INCIDENT COULD NOT BE CONFIRMED. THE CERTIFICATION OF STERILIZATION FOR THIS LOT NUMBER WAS REVIEWED AND THE STERILIZATION PROCESS MET ALL OF THE CRITERIA FOR ACCEPTANCE. AT THIS TIME, A MANUFACTURING RELATED CAUSE COULD NOT BE DETERMINED FOR THIS INCIDENT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD INFECTION AT THE INSERTION SITE WITH A BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: HEAD NURSE OF THE DEPARTMENT OF GENERAL MEDICINE, DURING THE INFUSION OF INDWELLING NEEDLES IN THE WARD IN (B)(6) 2020, SHE FOUND THAT INDWELLING NEEDLE APPEARED PUNCTURE SITE INFECTION IN THE LAST 10 DAYS. THE CUSTOMER SUSPECTED THAT THE INDWELLING NEEDLES WERE RELATED TO THE INDWELLING NEEDLES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD INFECTION AT THE INSERTION SITE WITH A BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: HEAD NURSE OF THE (B)(6), DURING THE INFUSION OF INDWELLING NEEDLES IN THE WARD IN (B)(6) 2020, SHE FOUND THAT INDWELLING NEEDLE APPEARED PUNCTURE SITE INFECTION IN THE LAST 10 DAYS. THE CUSTOMER SUSPECTED THAT THE INDWELLING NEEDLES WERE RELATED TO THE INDWELLING NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702567 BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 383312 9031833 30382903833123

    Patients

    Seq Age Sex Outcome Treatment
    1 Other