BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 10860060 · Received November 18, 2020

    Report

    Report Number
    2243072-2020-01853
    Event Type
    Malfunction
    Date Received
    November 18, 2020
    Date of Event
    October 8, 2020
    Report Date
    December 13, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION HAS BEEN UPDATED / CORRECTED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER EXPERIENCED LEAKAGE AT THE CONNECTION SITE AND CATHETER ADAPTER / HUB DEFORMED/DEFECTIVE -MOLDING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON 9-OCT-2020, THE INITIAL REPORTER RECEIVED AN EMAIL FROM A COLLEAGUE REGARDING THE ISSUE. IT WAS BROUGHT TO THEIR ATTENTION ON (B)(6) 2020 THAT AN IV THE COLLEAGUE PLACE IN THE MORNING OF THE SAME DATE DISCONNECTED WHERE THE T-CONNECTOR ATTACHED TO THE ACTUAL IV CATHETER. THE PATIENT SUSTAINED NO HARM. ANOTHER COLLEAGUE WAS IN THE VICINITY AND SAID THAT THE ISSUE HAPPENED ON (B)(6) 2020 IN THE OPERATING ROOM AND HAS HAPPENED BEFORE IN THE OPERATING ROOM ALSO. THE COLLEAGUE STATED THAT THEY HAVE NOTICED AN UP TICK IN LEAKING CONNECTIONS AT THIS SAME AREA AT LEAST THREE TIMES IN THE PAST ONE TO TWO MONTHS. SEVERAL BOND NURSES STATED THAT THEY WERE EXPERIENCING THE SAME THING. THEY DID NOT BELIEVE THIS WAS AN IV NURSE PHENOMENON. THE ISSUE WAS HAPPENING REGARDLESS OF WHICH IV NURSE OR PERSONNEL PLACES THE IV. D.1. MEDICAL DEVICE BRAND NAME: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER. D.1. COMMON DEVICE NAME: INTRAVASCULAR CATHETER. D.2. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. D.2. MEDICAL DEVICE TYPE: F OZ. D.4. MEDICAL DEVICE CATALOG#: 381433. D.4. MEDICAL DEVICE LOT#: 0016730. D.4. MEDICAL DEVICE EXPIRATION DATE: 2022-12-31. D.4. UNIQUE IDENTIFIER (UDI)#: (B)(4). G.1. MANUFACTURING LOCATION: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. G.5. PMA/510(K)#: K952861. H.4. DEVICE MANUFACTURE DATE: 2020-01-16.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER EXPERIENCED LEAKAGE AT THE CONNECTION SITE AND CATHETER ADAPTER / HUB DEFORMED/DEFECTIVE -MOLDING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON 9-OCT-2020, THE INITIAL REPORTER RECEIVED AN EMAIL FROM A COLLEAGUE REGARDING THE ISSUE. IT WAS BROUGHT TO THEIR ATTENTION ON (B)(6) 2020 THAT AN IV THE COLLEAGUE PLACE IN THE MORNING OF THE SAME DATE DISCONNECTED WHERE THE T-CONNECTOR ATTACHED TO THE ACTUAL IV CATHETER. THE PATIENT SUSTAINED NO HARM. ANOTHER COLLEAGUE WAS IN THE VICINITY AND SAID THAT THE ISSUE HAPPENED ON (B)(6) 2020 IN THE OPERATING ROOM AND HAS HAPPENED BEFORE IN THE OPERATING ROOM ALSO. THE COLLEAGUE STATED THAT THEY HAVE NOTICED AN UP TICK IN LEAKING CONNECTIONS AT THIS SAME AREA AT LEAST THREE TIMES IN THE PAST ONE TO TWO MONTHS. SEVERAL BOND NURSES STATED THAT THEY WERE EXPERIENCING THE SAME THING. THEY DID NOT BELIEVE THIS WAS AN IV NURSE PHENOMENON. THE ISSUE WAS HAPPENING REGARDLESS OF WHICH IV NURSE OR PERSONNEL PLACES THE IV.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER EXPERIENCED LEAKAGE AT THE CONNECTION SITE AND CATHETER ADAPTER/HUB DEFORMED/DEFECTIVE -MOLDING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON(B)(6) 2020, THE INITIAL REPORTER RECEIVED AN EMAIL FROM A COLLEAGUE REGARDING THE ISSUE. IT WAS BROUGHT TO THEIR ATTENTION ON (B)(6)2020 THAT AN IV THE COLLEAGUE PLACE IN THE MORNING OF THE SAME DATE DISCONNECTED WHERE THE T-CONNECTOR ATTACHED TO THE ACTUAL IV CATHETER. THE PATIENT SUSTAINED NO HARM. ANOTHER COLLEAGUE WAS IN THE VICINITY AND SAID THAT THE ISSUE HAPPENED ON (B)(6) 2020 IN THE OR AND HAS HAPPENED BEFORE IN THE OR ALSO. THE COLLEAGUE STATED THAT THEY HAVE NOTICED AN UP TICK IN LEAKING CONNECTIONS AT THIS SAME AREA AT LEAST THREE TIMES IN THE PAST ONE TO TWO MONTHS. SEVERAL BOND NURSES STATED THAT THEY WERE EXPERIENCING THE SAME THING. THEY DID NOT BELIEVE THIS WAS AN IV NURSE PHENOMENON. THE ISSUE WAS HAPPENING REGARDLESS OF WHICH IV NURSE OR PERSONNEL PLACES THE IV.

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. (B)(4). DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNSPECIFIED BD T-CONNECTOR EXPERIENCED LEAKAGE AT THE CONNECTION SITE AND CATHETER ADAPTER/HUB DEFORMED/DEFECTIVE, MOLDING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: UNKNOWN, BATCH NO.: REPORTED 016730. THE SUSPECTED LOT NUMBER FOR THE CONNECTOR IS 4553352. ON 9-OCT-2020, THE INITIAL REPORTER RECEIVED AN EMAIL FROM A COLLEAGUE REGARDING THE ISSUE. IT WAS BROUGHT TO THEIR ATTENTION ON 09-OCT-2020 THAT AN IV THE COLLEAGUE PLACE IN THE MORNING OF THE SAME DATE DISCONNECTED WHERE THE T-CONNECTOR ATTACHED TO THE ACTUAL IV CATHETER. THE PATIENT SUSTAINED NO HARM. ANOTHER COLLEAGUE WAS IN THE VICINITY AND SAID THAT THE ISSUE HAPPENED ON 08-OCT-2020 IN THE OR AND HAS HAPPENED BEFORE IN THE OR ALSO. THE COLLEAGUE STATED THAT THEY HAVE NOTICED AN UP TICK IN LEAKING CONNECTIONS AT THIS SAME AREA AT LEAST THREE TIMES IN THE PAST ONE TO TWO MONTHS. SEVERAL BOND NURSES STATED THAT THEY WERE EXPERIENCING THE SAME THING. THEY DID NOT BELIEVE THIS WAS AN IV NURSE PHENOMENON. THE ISSUE WAS HAPPENING REGARDLESS OF WHICH IV NURSE OR PERSONNEL PLACES THE IV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1330579 BD INSYTE AUTOGUARD SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 0016730

    Patients

    Seq Age Sex Outcome Treatment
    1