BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAF-T-INTIMA W/Y ADAPTER GN 18GA X 1.0IN

    MDR report key: 11168035 · Received January 13, 2021

    Report

    Report Number
    9610847-2021-00010
    Event Type
    Injury
    Date Received
    January 13, 2021
    Date of Event
    December 17, 2020
    Report Date
    March 10, 2021
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    00382903833467
    PMA / PMN Number
    K013800
    Adverse Event
    Yes
    Product Problem
    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 COMPLETED FOR PROVIDED LOT NUMBER 9122995. 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. TO AID IN THE INVESTIGATION OF THIS INCIDENT, A REPRESENTATIVE SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE SAMPLE WAS FUNCTIONALLY TESTED TO MEASURE THE PULL FORCE OF THE INSERTER, THE RUBBER CAP, AND THE COVER FORCE. ALL OF THE TEST RESULTS WERE WITHIN SPECIFICATION. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED OF THIS INCIDENT. (B)(4) SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SAF-T-INTIMA W/Y ADAPTER GN 18GA X 1.0IN SAFETY MECHANISM WAS DIFFICULT TO DISENGAGE ON 25 OCCASIONS. THIS CAUSED A NEEDLE STICK INJURY FOR THE NURSE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE INDWELLING NEEDLE WAS ALWAYS PUNCTURED IN THE WARD BEFORE THE SURGERY IN THE HOSPITAL. ON TODAY'S MORNING, WHEN THE NURSE USED 18G PEGASUS TO DO THE PUNCTURING, SHE FOUND THE NEEDLE WAS DIFFICULT TO DISENGAGE AFTER SUCCESSFUL DELIVERING. NURSE DIDN'T WANT TO DO THE PUNCTURING AGAIN SINCE SHE SAW LOTS OF BLOOD IN THE EXTENSION TUBE, SO SHE WANTED TO CLOSE THE CLAMP. WHEN NURSE WAS CLOSING THE CLAMP, SHE WAS INJURED BY THE HALF- WITHDRAWN NEEDLE. PATIENT WAS CONFIRMED WITH HBV, AND NURSE WAS INJECTED THE VACCINE AND WAITING THE EXAMINED REPORT. THE HEAD NURSE AND THE INJURED NURSE WERE ANXIETY, THEY WANTED A FULL RESEARCH AND THE RESULT OF THIS BATCH, AND THEY DIDN'T WANT TO SEE THIS THING AGAIN. SINCE THIS WAS A SERIOUS INCIDENT, IT HAD BEEN REPORTED TO THE EQUIPMENT DEPARTMENT WITH THE NEEDLE STICK INJURY PROCESS.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SAF-T-INTIMA W/Y ADAPTER GN 18GA X 1.0IN SAFETY MECHANISM WAS DIFFICULT TO DISENGAGE ON 25 OCCASIONS. THIS CAUSED A NEEDLE STICK INJURY FOR THE NURSE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE INDWELLING NEEDLE WAS ALWAYS PUNCTURED IN THE WARD BEFORE THE SURGERY IN THE HOSPITAL. ON TODAY'S MORNING, WHEN THE NURSE USED 18G PEGASUS TO DO THE PUNCTURING, SHE FOUND THE NEEDLE WAS DIFFICULT TO DISENGAGE AFTER SUCCESSFUL DELIVERING. NURSE DIDN'T WANT TO DO THE PUNCTURING AGAIN SINCE SHE SAW LOTS OF BLOOD IN THE EXTENSION TUBE, SO SHE WANTED TO CLOSE THE CLAMP. WHEN NURSE WAS CLOSING THE CLAMP, SHE WAS INJURED BY THE HALF- WITHDRAWN NEEDLE. PATIENT WAS CONFIRMED WITH HBV, AND NURSE WAS INJECTED THE VACCINE AND WAITING THE EXAMINED REPORT. THE HEAD NURSE AND THE INJURED NURSE WERE ANXIETY, THEY WANTED A FULL RESEARCH AND THE RESULT OF THIS BATCH, AND THEY DIDN'T WANT TO SEE THIS THING AGAIN. SINCE THIS WAS A SERIOUS INCIDENT, IT HAD BEEN REPORTED TO THE EQUIPMENT DEPARTMENT WITH THE NEEDLE STICK INJURY PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62109 SAF-T-INTIMA W/Y ADAPTER GN 18GA X 1.0IN INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 9122995 00382903833467

    Patients

    Seq Age Sex Outcome Treatment
    1 Other