BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM

    MDR report key: 10253531 · Received July 9, 2020

    Report

    Report Number
    9610847-2020-00205
    Event Type
    Injury
    Date Received
    July 9, 2020
    Date of Event
    July 8, 2020
    Report Date
    September 9, 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

    CORRECTION: THE AWARENESS DATE WAS UPDATED. THE FOLLOWING FIELDS HAVE BEEN CHANGED: B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. G.4. DATE RECEIVED BY MANUFACTURER: 2020-07-08.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 9086671 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, THREE PICTURE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM; HOWEVER, THE PRODUCT DESCRIBED IN THIS INCIDENT WAS NOT OBSERVED IN THE PICTURE SAMPLES AND THEREFORE, WAS UNAVAILABLE FOR EVALUATION OR TESTING. THE PICTURE SAMPLES DID APPEAR TO DISPLAY THE REPORTED COMPLAINT OF INFECTION. AFTER THE SAF-T-INTIMA PRODUCT IS MANUFACTURED, IT IS SENT OF STERILIZATION. THE STERILIZATION RECORDS FOR THIS LOT NUMBER WERE REVIEWED AND ALL CRITERIA WAS MET. AT THIS TIME, A MANUFACTURING RELATED CAUSE CANNOT BE IDENTIFIED FOR THIS INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DURING THE INFUSION, THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM PUNCTURE SITE APPEARED TO BE INFECTED "IN THE LAST 10 DAYS". THE NEEDLE WAS REMOVED, AND STERILIZATION WAS PERFORMED BEFORE ANOTHER PUNCTURE WAS MADE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "DURING THE INFUSION OF INDWELLING NEEDLES IN THE WARD IN (B)(6) 2020, SHE FOUND THAT 3 INDWELLING NEEDLES (9031833(1) 9086671(2)) APPEARED PUNCTURE SITE INFECTION IN THE LAST 10 DAYS. THE CUSTOMER SUSPECTED THAT THE INDWELLING NEEDLES WERE RELATED TO THE INDWELLING NEEDLES, AND HOPED THAT OUR COMPANY WOULD PAY ATTENTION TO IT AFTER THE INFECTION OF THE PUNCTURE SITE WAS FOUND, THE INDWELLING NEEDLE WAS REMOVED IMMEDIATELY, AND NO DIFFICULTY IN PUNCTURE WAS FOUND DURING THE PUNCTURE PROCESS. STERILIZATION WAS FOLLOWED TO STERILIZE BEFORE PUNCTURE"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DURING THE INFUSION, THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM PUNCTURE SITE APPEARED TO BE INFECTED "IN THE LAST 10 DAYS". THE NEEDLE WAS REMOVED, AND STERILIZATION WAS PERFORMED BEFORE ANOTHER PUNCTURE WAS MADE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "DURING THE INFUSION OF INDWELLING NEEDLES IN THE WARD IN (B)(6) 2020, SHE FOUND THAT 3 INDWELLING NEEDLES (9031833(1) 9086671(2)) APPEARED PUNCTURE SITE INFECTION IN THE LAST 10 DAYS. THE CUSTOMER SUSPECTED THAT THE INDWELLING NEEDLES WERE RELATED TO THE INDWELLING NEEDLES, AND HOPED THAT OUR COMPANY WOULD PAY ATTENTION TO IT AFTER THE INFECTION OF THE PUNCTURE SITE WAS FOUND, THE INDWELLING NEEDLE WAS REMOVED IMMEDIATELY, AND NO DIFFICULTY IN PUNCTURE WAS FOUND DURING THE PUNCTURE PROCESS. STERILIZATION WAS FOLLOWED TO STERILIZE BEFORE PUNCTURE".

    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 THE DURING THE INFUSION, THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM PUNCTURE SITE APPEARED TO BE INFECTED "IN THE LAST 10 DAYS". THE NEEDLE WAS REMOVED, AND STERILIZATION WAS PERFORMED BEFORE ANOTHER PUNCTURE WAS MADE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "DURING THE INFUSION OF INDWELLING NEEDLES IN THE WARD IN (B)(6) 2020, SHE FOUND THAT 3 INDWELLING NEEDLES (9031833(1), 9086671(2)) APPEARED PUNCTURE SITE INFECTION IN THE LAST 10 DAYS. THE CUSTOMER SUSPECTED THAT THE INDWELLING NEEDLES WERE RELATED TO THE INDWELLING NEEDLES, AND HOPED THAT OUR COMPANY WOULD PAY ATTENTION TO IT AFTER THE INFECTION OF THE PUNCTURE SITE WAS FOUND, THE INDWELLING NEEDLE WAS REMOVED IMMEDIATELY, AND NO DIFFICULTY IN PUNCTURE WAS FOUND DURING THE PUNCTURE PROCESS. STERILIZATION WAS FOLLOWED TO STERILIZE BEFORE PUNCTURE"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715898 BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 383312 9086671 30382903833123

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention