BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD SAF-T-INTIMA SAFETY SYSTEM WITH Y ADAPTER 22 GA 0.75 IN

    MDR report key: 10405460 · Received August 13, 2020

    Report

    Report Number
    9610847-2020-00240
    Event Type
    Injury
    Date Received
    August 13, 2020
    Date of Event
    July 11, 2020
    Report Date
    September 9, 2020
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    30382903833239
    PMA / PMN Number
    K013800
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 8/20/2020. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER: 0062180 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, BOTH PICTURE AND PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE RETURNED REPRESENTATIVE SAMPLE WAS FUNCTIONALLY TESTED AND NO ABNORMALITIES WERE FOUND WHEN REMOVING THE NEEDLE. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE IDENTIFIED FOR THIS REPORTED INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER 22 GA 0.75 IN EXPERIENCED SAFETY MECHANISM FAILURE, "SCRAPING" ONE OF THE NURSES. THE NURSE RECEIVED MEDICAL ATTENTION IN THE ER WHERE NO ADDITIONAL HARM / INJURY WAS IDENTIFIED. THE FOLLOWING DATE RECEIVED FOR INTAKE: ON (B)(6) 2020. MATERIAL NO. 383323, BATCH NO. 0062180. EVENT DESCRIPTION: AN INTIMA CATHETER FAILED TO RETRACT APPROPRIATELY AND ONE OF THE NURSES GOT SCRAPED WITH IT. HE WENT TO ER AND IS OK.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER 22 GA 0.75 IN EXPERIENCED SAFETY MECHANISM FAILURE, "SCRAPING" ONE OF THE NURSES. THE NURSE RECEIVED MEDICAL ATTENTION IN THE ER WHERE NO ADDITIONAL HARM/INJURY WAS IDENTIFIED. THE FOLLOWING DATE RECEIVED FOR INTAKE: (B)(6) 2020. MATERIAL NO. 383323, BATCH NO. 0062180. EVENT DESCRIPTION: AN INTIMA CATHETER FAILED TO RETRACT APPROPRIATELY AND ONE OF THE NURSES GOT SCRAPED WITH IT. HE WENT TO EMERGENCY ROOM AND IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869733 BD SAF-T-INTIMA SAFETY SYSTEM WITH Y ADAPTER 22 GA 0.75 IN INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 383323 0062180 30382903833239

    Patients

    Seq Age Sex Outcome Treatment
    1 Other