BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17931339 · Received October 13, 2023

    Report

    Report Number
    1710034-2023-01194
    Event Type
    Malfunction
    Date Received
    October 13, 2023
    Date of Event
    September 28, 2023
    Report Date
    November 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
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE REPRESENTATIVE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED TEN SEALED 20GA X 1.00IN. INSYTE AUTOGUARD BC UNITS FROM LOT NUMBER 3142661. A PENETRATION AND DRAG TEST WAS PERFORMED AND ALL UNITS PASSED SPECIFICATIONS. AFTER TESTING, EACH CATHETER WAS ADVANCED SLIGHTLY OFF THE NEEDLE TO BREAK TIP ADHESION AND RETRACTED. NO RESISTANCE FROM THE CATHETER WAS DETECTED. THE RETURNED UNITS PROVIDED FOR EVALUATION MET AND PERFORMED PER THE REQUIRED MANUFACTURING SPECIFICATIONS. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE FAILURES STATED IN THE REPORT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL THE CATHETER BACKED OUT OF THE VEIN. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DATE OF OCCURRENCES: (B)(6) 2023. NUMBER OF PRODUCT AFFECTED: APPROXIMATELY 20 INSYTES DURING THIS SPAN OF TIME WITH BOTH 20 GAUGE AND 22 GAUGE IV CATHETERS. DESCRIPTION OF WHAT HAPPENED: MULTIPLE NURSING STAFF REPORTED THAT THE IV CATHETER WILL NOT ADVANCE OFF OF THE NEEDLE ONCE IN THE VEIN. PRODUCT # AND LOT #: 22GA (382523). LOT# 3181571. LOT# 3117895. 20GA (382533). LOT# 3142661. WAS THE COURSE OF TREATMENT ALTERED?: YES, THE PATIENT HAD TO BE STUCK MORE THAN ONCE FOR AN IV START. ANY HARM TO THE PATIENT?: NO, OTHER THAN HAVING TO HAVE A SECOND IV START. WE PULLED ALL OF THE AFFECTED LOTS FROM OUR STOREROOM THAT I CAN SEND BACK IF YOU WOULD LIKE. ADD INFO RECEIVED: 3RD CUSTOMER RESPONSE: ¿ WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? DELAY IN TREATMENT DUE TO MORE THAN 1 IV STICK. ¿ WHAT TYPE OF PROCEDURE IS BEING PERFORMED? IV START. ¿ WHAT WAS THE MEDICATION/FLUID IN USE AT THE TIME OF THE EVENT? N/A. 4TH CUSTOMER RESPONSE: THE ADHESION WAS BROKE BEFORE INSERTION WITH THE IV ATTEMPTS. THE NURSES STATE THAT THE CATHETER WON'T THREAD INTO THE VEIN AND WHEN THEY WOULD PUSH THE BUTTON TO RETRACT THE NEEDLE, THE CATHETER WOULD ALSO RETRACT FROM THE VEIN WITH THE NEEDLE. I AM NOT ABLE TO GIVE YOU SPECIFIC DATES/TIMES AS IT WAS MULTIPLE NURSES STATING THE SAME THING DURING THOSE DATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683132 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3142661 00382903825332

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown