BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 24GA 0.75IN (0.7 X 19 MM)

    MDR report key: 12453701 · Received September 10, 2021

    Report

    Report Number
    1710034-2021-00799
    Event Type
    Malfunction
    Date Received
    September 10, 2021
    Date of Event
    August 13, 2021
    Report Date
    November 19, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818129
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 10/28/2021. H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPH SUBMITTED FOR EVALUATION. BD RECEIVED ONE 24GA INSYTE AUTOGUARD CATHETER FROM LOT NUMBER 0191501. IN ADDITION, ONE 3ML SYRINGE WAS ALSO RETURNED. A VISUAL INSPECTION OF THE RETURNED UNIT DID NOT FIND ANY DAMAGE TO THE COMPONENTS. THE UNIT WAS TESTED FOR LEAKAGE AND WAS SUBSEQUENTLY FOUND TO LEAK NEAR THE NOSE OF THE ADAPTER. THE REPORTED ISSUE WAS CONFIRMED. FURTHER MICROSCOPIC INSPECTION FOUND THAT THERE WAS AN APERTURE IN THE CATHETER TUBING JUST ABOVE THE NOSE OF THE ADAPTER. PUNCTURE TO THE TUBING MAY OCCUR IN THE CLINICIAN SETTING DURING TIP ADHESION BREAK OR DURING VENIPUNCTURE IF THE NEEDLE IS ADVANCED AT A WRONG ANGLE OR IF THE NEEDLE IS MOVED UP AND DOWN THE CATHETER TUBING. IN THE MANUFACTURING IT MAY OCCUR DUE TO A MISALIGNED SWAGE PIN OR A SPEAR THROUGH DURING THE MATING OF THE CATHETER AND NEEDLE. THE APERTURE WAS IN AN IRREGULAR SHAPE WHICH IS INCONSISTENT WITH WHAT IS COMMONLY SEEN FORM A SPEAR THROUGH (NEEDLE THROUGH CATHETER) OR A SWAGE PIN CAUSED DEFECTS. NOR DOES THE SHAPE MATCH KNOWN EXTRUSION DEFECTS OF THE TUBING. ADDITIONALLY, WHEN A SPEAR THROUGH ORIGINATES DURING THE MANUFACTURING PROCESS, A NEEDLE WOULD REMAIN PIERCING A CATHETER TUBING, MAKING A VENIPUNCTURE ATTEMPT UNLIKELY. BASED ON THE PHOTO AND PHYSICAL EVIDENCE A VENIPUNCTURE WAS ATTEMPTED, THEREFORE MAKING A MANUFACTURING CAUSED SPEAR THROUGH AN UNLIKELY ROOT CAUSE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPH SUBMITTED FOR EVALUATION. BD RECEIVED ONE PHOTO. THE PROVIDED PHOTO SHOWED A VIEW OF A DEVICE ATTACHED TO AN EMPTY SLIP LUER SYRINGE. IT WAS NOTED THAT A WHITE SUBSTANCE COULD BE SEEN ON THE EXTERIOR OF THE SLIP LUER NEAR THE LUER THREADS OF THE CATHETER; HOWEVER, NO DAMAGE OR LEAK WAS NOTED ON THE CATHETER. ADDITIONALLY, NO FLUID COULD BE SEEN INSIDE THE CATHETER OR SYRINGE. UNFORTUNATELY, THE PHOTO DID NOT PROVIDE SUFFICIENT DETAIL TO IDENTIFY OR CONFIRM THE REPORTED DEFECT. 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 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 24GA 0.75IN (0.7 X 19 MM) LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKAGE BETWEEN CATHETER AND HUB".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 24GA 0.75IN (0.7 X 19 MM) LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKAGE BETWEEN CATHETER AND HUB."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED AS A DEFAULT.(B)(6). 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 · 1

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD SHIELDED IV CATHETER 24GA 0.75IN (0.7 X 19 MM) LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKAGE BETWEEN CATHETER AND HUB".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1351329 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 24GA 0.75IN (0.7 X 19 MM) INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381812 0191501 00382903818129

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown