BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD SAF-T-INTIMA SAFETY SYSTEM WITH REMOVABLE PRN 22 GA 0.75 IN (NON-DEHP)

    MDR report key: 11953588 · Received June 7, 2021

    Report

    Report Number
    9610847-2021-00258
    Event Type
    Injury
    Date Received
    June 7, 2021
    Date of Event
    May 10, 2021
    Report Date
    June 17, 2021
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED LOT NUMBER 9275844, 0266562, 9175121 AND 0120557. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH REMOVABLE PRN 22 GA 0.75 IN (NON-DEHP) INFECTIONS WERE OBSERVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I WOULD LIKE TO CONTACT THE BD PRODUCT MANAGER TO KNOW IF THERE HAVE BEEN ANY CHANGES IN THE LAST FEW MONTHS ON THE KT INTIMA REF.383328. OUR NURSES ARE TALKING ABOUT CHANGES IN THE NEEDLE.. AND ARE NOTICING MORE AND MORE INFECTIONS AT THE PUNCTURE POINT AND WE WOULD LIKE TO KNOW THE CAUSE..."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0266562. MEDICAL DEVICE EXPIRATION DATE: 2024-09-30. DEVICE MANUFACTURE DATE: (B)(6) 2020. MEDICAL DEVICE LOT #: 9175121, MEDICAL DEVICE EXPIRATION DATE: 2023-06-30, DEVICE MANUFACTURE DATE: (B)(6) 2019. MEDICAL DEVICE LOT #: 9275844, MEDICAL DEVICE EXPIRATION DATE: 2024-09-30, DEVICE MANUFACTURE DATE: (B)(6) 2019. MEDICAL DEVICE LOT #: 0120557, MEDICAL DEVICE EXPIRATION DATE: 2024-04-30, DEVICE MANUFACTURE DATE: (B)(6) 2020.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH REMOVABLE PRN 22 GA 0.75 IN (NON-DEHP) INFECTIONS WERE OBSERVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I WOULD LIKE TO CONTACT THE BD PRODUCT MANAGER TO KNOW IF THERE HAVE BEEN ANY CHANGES IN THE LAST FEW MONTHS ON THE KT INTIMA (B)(4). OUR NURSES ARE TALKING ABOUT CHANGES IN THE NEEDLE AND ARE NOTICING MORE AND MORE INFECTIONS AT THE PUNCTURE POINT AND WE WOULD LIKE TO KNOW THE CAUSE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841366 BD SAF-T-INTIMA SAFETY SYSTEM WITH REMOVABLE PRN 22 GA 0.75 IN (NON-DEHP) INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 0120557

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention