BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8731699 · Received June 25, 2019

    Report

    Report Number
    1710034-2019-00664
    Event Type
    Malfunction
    Date Received
    June 25, 2019
    Date of Event
    June 6, 2019
    Report Date
    August 16, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903815112
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLES PROVIDED. BD RECEIVED THREE USED INSTYE AUTOGUARD 24GA UNITS IN OPENED PACKAGES FROM CATALOG NUMBER 381511, LOT NUMBER 9049972. THROUGH THE VISUAL/MICROSCOPIC EVALUATION, THE NEEDLES WERE PUSHED TO THE OUT POSITION WHERE NO MECHANICAL OR PHYSICAL DAMAGE WAS OBSERVED TO ANY OF THE COMPONENTS. THE NEEDLES HAD THE PROPER BEVEL CUT AND THE SECONDARY BEVEL WAS PRESENT. THE NEEDLES WERE NOT BENT, PINCHED OR HAD GRIPPER DAMAGE TO THE NEEDLE. THE CANNULA TIP QUALITY RATING AND TIP GRADING WERE ALL FOUND ACCEPTABLE. A FUNCTIONAL TEST WAS PERFORMED WHERE NEEDLE RETRACTIONS WERE SUCCESSFUL. THERE WAS NO DELAYED REACTION WAS OBSERVED. A FLASHBACK TEST WAS PERFORMED UTILIZING A LAB SUPPLIED ARTIFICIAL VEIN WITH A RED DYE/WATER MIX IN WHICH WE PERFORMED A SIMULATION OF THE VENIPUNCTURE. FLASHBACK WAS OBSERVED. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER HAD A NEEDLE RETRACTION FAILURE. THIS OCCURRED ON 3 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 381511 BATCH NO.: 9049972. IT WAS REPORTED BY BD ASSOCIATE THAT ONE BAG WITH THREE USED UNITS WERE RECEIVED AT THE SITE. WRITTEN ON THE BAG WAS THE FOLLOWING: NO THREAD, NEEDLE DIDN'T RETRACT, NO FLASH BUT VEIN BLOWN. VERBATIM: I RECEIVED THE SAMPLES FOR PR¿S 954966, 955098, 955030 AND IN ADDITION I RECEIVED THE FOLLOWING SAMPLES. ONE BAG WITH THREE USED RETRACTED UNITS IN OPENED PACKAGES FROM CATALOG NUMBER 381511, 9049972. WRITTEN ON THE BAG IT SAYS: 1. NO THREAD 2. NEEDLE DIDN¿T RETRACT 3. NO FLASH BUT VEIN BLOWN 4. NO THREAD.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (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-N¿ AUTOGUARD¿ SHIELDED IV CATHETER HAD A NEEDLE RETRACTION FAILURE. THIS OCCURRED ON 3 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 381511, BATCH NO.: 9049972. IT WAS REPORTED BY BD ASSOCIATE THAT ONE BAG WITH THREE USED UNITS WERE RECEIVED AT THE SITE. WRITTEN ON THE BAG WAS THE FOLLOWING: NO THREAD, NEEDLE DIDN'T RETRACT, NO FLASH BUT VEIN BLOWN. VERBATIM: I RECEIVED THE SAMPLES FOR PR¿S 954966, 955098, 955030 AND IN ADDITION I RECEIVED THE FOLLOWING SAMPLES. ONE BAG WITH THREE USED RETRACTED UNITS IN OPENED PACKAGES FROM CATALOG NUMBER 381511, 9049972. WRITTEN ON THE BAG IT SAYS: NO THREAD, NEEDLE DIDN¿T RETRACT, NO FLASH BUT VEIN BLOWN, NO THREAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526370 BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9049972 30382903815112

    Patients

    Seq Age Sex Outcome Treatment
    1 Other