BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL

    MDR report key: 17740555 · Received September 13, 2023

    Report

    Report Number
    1710034-2023-01051
    Event Type
    Malfunction
    Date Received
    September 13, 2023
    Date of Event
    August 28, 2023
    Report Date
    October 3, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825332
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    CORRECTION: AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE MDR 1710034-2023-01051 IS A DUPLICATE OF 1710034-2023-01055 THIS SUPPLEMENTAL IS TO CANCEL MDR 1710034-2023-01051.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL THE NEEDLE DID NOT PROPERLY RETRACT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SAID THEY HAVE HAD SOME ISSUES WITH THE PUSH PINS NOT PUSHING? THEY GAVE ME A FEW AND THEY ARE FROM LOT # 3166524. PLEASE LET ME KNOW IF I NEED TO REACH OUT TO SOMEONE ELSE IF THIS ISN¿T YOUR ITEM. THANK YOU. ADDITIONAL INFORMATION RECEIVED ON 01-SEP-2023. ARE YOU ABLE TO CONFIRM THE DATE OF INCIDENT? (B)(6) 2023. 2. PLEASE DESCRIBE HOW WAS THE ISSUE HAPPENED. WHEN THE CATHETER WAS INSERTED INTO THE VESSEL, THE WHITE SAFETY BUTTON WAS PUSHED. THE NEEDLE WOULD NOT RETRACT. THIS HAPPENED WITH SEVERAL PATIENTS. 3.WAS THERE ANY PATIENT INVOLVEMENT? WAS THERE ANY ADVERSE EVENT OR SERIOUS INJURY? THE CATHETERS WERE USED ON SEVERAL PATIENTS, BUT THERE WAS NO PATIENT OR STAFF INJURY. 4. WHAT TYPE OF PROCEDURE WAS BEING PERFORMED? IV CATHETER INSERTION 5. WAS THE PROCEDURE COMPLETED AS PLANNED? UNSURE 6. PLEASE ADVISE THE QUANTITY OF DEFECTIVE PRODUCT. 7. IS SAMPLE AVAILABLE TO BE RETURN FOR EVALUATION? IF NO, IS PHOTO AVAILABLE? PRODUCT SEQUESTERED AND AWAITING REP TO PICK UP.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL THE NEEDLE DID NOT PROPERLY RETRACT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SAID THEY HAVE HAD SOME ISSUES WITH THE PUSH PINS NOT PUSHING? THEY GAVE ME A FEW AND THEY ARE FROM LOT # 3166524. PLEASE LET ME KNOW IF I NEED TO REACH OUT TO SOMEONE ELSE IF THIS ISN¿T YOUR ITEM. THANK YOU. ADDITIONAL INFORMATION RECEIVED ON 01-SEP-2023. ARE YOU ABLE TO CONFIRM THE DATE OF INCIDENT? (B)(6) 2023. 2. PLEASE DESCRIBE HOW WAS THE ISSUE HAPPENED. WHEN THE CATHETER WAS INSERTED INTO THE VESSEL, THE WHITE SAFETY BUTTON WAS PUSHED. THE NEEDLE WOULD NOT RETRACT. THIS HAPPENED WITH SEVERAL PATIENTS. 3. WAS THERE ANY PATIENT INVOLVEMENT? WAS THERE ANY ADVERSE EVENT OR SERIOUS INJURY? THE CATHETERS WERE USED ON SEVERAL PATIENTS, BUT THERE WAS NO PATIENT OR STAFF INJURY. 4. WHAT TYPE OF PROCEDURE WAS BEING PERFORMED? IV CATHETER INSERTION. 5. WAS THE PROCEDURE COMPLETED AS PLANNED? UNSURE. 6. PLEASE ADVISE THE QUANTITY OF DEFECTIVE PRODUCT. 7. IS SAMPLE AVAILABLE TO BE RETURN FOR EVALUATION? IF NO, IS PHOTO AVAILABLE? PRODUCT SEQUESTERED AND AWAITING REP TO PICK UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1615178 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3166524 00382903825332

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown