BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD GN 18GA X 1.16IN

    MDR report key: 11674565 · Received April 15, 2021

    Report

    Report Number
    1710034-2021-00302
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Date of Event
    March 17, 2021
    Report Date
    May 26, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814443
    PMA / PMN Number
    K952861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION: 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. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF INSYTE AUTOGUARD GN 18GA X 1.16IN EXPERIENCED AN INCOMPLETE FLUSH DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED WE GET AN INITIAL FLASHBACK OF BLOOD BUT THEN NO FURTHER BLOOD FLOW AND IT WON'T FLUSH." VERBATIM: COMPLAINTS TEAM: MY CUSTOMER HAS IDENTIFIED THREE LOTS THAT ARE GIVING THEM TROUBLE FROM IN-SYTE AUTOGUARD 18G (381444) AND 20G (381433) AND ALERTED ME YESTERDAY. THE LOT NUMBERS ARE AS FOLLOWS: 0213316, 0176401, AND 0274682. UNFORTUNATELY, HE WAS NOT ABLE TO TELL ME WHAT LOT COORDINATES WITH WHICH GAUGE TO REPORT IT. CAN WE LOOK UP THESE LOTS? IT APPEARS FROM THE DETAILS BELOW THAT THE CATHETER WAS CLOGGED SOMEHOW AND THE PATIENT HAD TO GET STUCK AGAIN. NO ONE WAS HURT BY THE CATHETERS BUT IT IS INCONVENIENT TO THE NURSE AS WELL AS THE PATIENT. MOST OF THE ISSUES HAVE BEEN WITH THE 18G. I HAVE REACHED OUT TO THE UNIT MANAGER AND SHE IS SAVING THE IV CATHETERS FOR US TO RETURN. I AM REITERATING A PAST PROBLEM AND SINCE I ONLY REALLY WORK IN PERINATAL, I AM TRULY UNSURE OF ISSUES FOR OTHER UNITS WHO FREQUENTLY USE OUR IV CATHETERS (18 AND 20G). I HAVE HAD ABOUT 6 OTHER PEOPLE ON MY UNIT (WHO FREQUENTLY USE PUT IVS IN AND USE THESE) VERB THAT WE ARE HAVING ISSUES ON PEOPLE WITH GOOD HEALTHY VEINS WITH 18G.1 PROBLEM IS THAT ONCE INSERTED (AND IT SLIDES IN AS EXPECTED WITHOUT TROUBLE) WE GET AN INITIAL FLASHBACK OF BLOOD BUT THEN NO FURTHER BLOOD FLOW AND IT WON'T FLUSH AND THE SECOND IS THE CATHETER MIGHT SLIDE IN, GIVE SOME BLOOD FOR A FEW TUBES BUT THEN IT QUITS GIVING BLOOD AND MIGHT BE UNFLUSHABLE. I HAVE HAD TO STICK AN IV IN BECAUSE OF THIS AND THEN STICK AGAIN WITH A BUTTERFLY TO GET THE NEEDED BLOOD IN SOME CASES. I THOUGHT IT WAS JUST ME AND MAYBE MY TECHNIQUE (THOUGH I HAVE BEEN DOING THIS FOR 20+ YRS) BUT OTHERS ARE ALSO HAVING TROUBLE AND OUR PTS ARE THE ONES SUFFERING MULTIPLE STICKS. ANESTHESIA HAS ALSO VOUCHED FOR THIS (WE HAD A PT IN THE OR FOR A LEVEL 1 C/S WHO I GOT A 20 GAUGE IN HER WRIST AND IT FLUSHED BUT WOULDN'T RETURN BLOOD, SO THEY THE TRIED ABOUT 5-6 MORE TIMES IN THE OR BEFORE GETTING ONE INA VERY BAD PLACE; WE RESORTED AT END OF SURGERY TO USE A FOOT VEIN)..BUT I THINK OUR CATHETERS ARE A MAJOR PART OF THIS ISSUE: I DON'T HAVE A COMPILATION OF WHICH 18G ARE THE PROBLEM BUT I WILL GET THAT OVER THE NEXT FEW WEEKS I JUST WANTED YOU AS OUR SUPPLY PERSON TO HEAR OF THE ISSUE. I AM UNSURE IF OTHERS ARE HAVING THIS SAME ISSUE BUT I HAVE INCLUDED THE PRACTICE COUNCIL ON THIS TO SEE IF THERE IS OTHER INPUT HOUSEWIFE (THOUGH MY MEMBERSHIP IS LIMITED SO I AM NOT SURE IF WE WILL GET OTHER INPUT). THANK YOU AND I WILL GET THE TALLIED LIST OF NUMBERS WHEN I CAN."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0176401, MEDICAL DEVICE EXPIRATION DATE: 2023-05-31, DEVICE MANUFACTURE DATE: 2020-06-24. MEDICAL DEVICE LOT #: 0274682, MEDICAL DEVICE EXPIRATION DATE: 2023-09-30, DEVICE MANUFACTURE DATE: 2020-10-01. MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. 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 AN UNSPECIFIED NUMBER OF INSYTE AUTOGUARD GN 18GA X 1.16IN EXPERIENCED AN INCOMPLETE FLUSH DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED WE GET AN INITIAL FLASHBACK OF BLOOD BUT THEN NO FURTHER BLOOD FLOW AND IT WON'T FLUSH. COMPLAINTS TEAM- MY CUSTOMER HAS IDENTIFIED THREE LOTS THAT ARE GIVING THEM TROUBLE FROM IN-SYTE AUTOGUARD 18G (381444) AND 20G (381433) AND ALERTED ME YESTERDAY. THE LOT NUMBERS ARE AS FOLLOWS: 0213316, 0176401, AND 0274682. UNFORTUNATELY, HE WAS NOT ABLE TO TELL ME WHAT LOT COORDINATES WITH WHICH GAUGE TO REPORT IT. CAN WE LOOK UP THESE LOTS? IT APPEARS FROM THE DETAILS BELOW THAT THE CATHETER WAS CLOGGED SOMEHOW AND THE PATIENT HAD TO GET STUCK AGAIN. NO ONE WAS HURT BY THE CATHETERS BUT IT IS INCONVENIENT TO THE NURSE AS WELL AS THE PATIENT. MOST OF THE ISSUES HAVE BEEN WITH THE 18G. I HAVE REACHED OUT TO THE UNIT MANAGER AND SHE IS SAVING THE IV CATHETERS FOR US TO RETURN. I AM REITERATING A PAST PROBLEM. AND SINCE I ONLY REALLY WORK IN PERINATAL I AM TRULY UNSURE OF ISSUES FOR OTHER UNITS WHO FREQUENTLY USE OUR IV CATHETERS (18 AND 20G). I HAVE HAD ABOUT 6 OTHER PEOPLE ON MY UNIT (WHO FREQUENTLY USE PUT IVS IN AND USE THESE) VERB THAT WE ARE HAVING ISSUES ON PEOPLE WITH GOOD HEALTHY VEINS WITH 18G. PROBLEM IS THAT ONCE INSERTED (AND IT SLIDES IN AS EXPECTED WITHOUT TROUBLE) WE GET AN INITIAL FLASHBACK OF BLOOD BUT THEN NO FURTHER BLOOD FLOW AND IT WON'T FLUSH AND THE SECOND IS THE CATHETER MIGHT SLIDE IN, GIVE SOME BLOOD FOR A FEW TUBES BUT THEN IT QUITS GIVING BLOOD AND MIGHT BE UNFLUSHABLE. I HAVE HAD TO STICK AN IV IN BECAUSE OF THIS AND THEN STICK AGAIN WITH A BUTTERFLY TO GET THE NEEDED BLOOD IN SOME CASES. I THOUGHT IT WAS JUST ME AND MAYBE MY TECHNIQUE (THOUGH I HAVE BEEN DOING THIS FOR 20+ YRS) BUT OTHERS ARE ALSO HAVING TROUBLE AND OUR PTS ARE THE ONES SUFFERING MULTIPLE STICKS. ANESTHESIA HAS ALSO VOUCHED FOR THIS (WE HAD A PT IN THE OR FOR A LEVEL 1 C/S WHO I GOT A 20 GAUGE IN HER WRIST AND IT FLUSHED BUT WOULDN'T RETURN BLOOD, SO THEY THE TRIED ABOUT 5-6 MORE TIMES IN THE OR BEFORE GETTING ONE INA VERY BAD PLACE; WE RESORTED AT END OF SURGERY TO USE A FOOT VEIN). BUT I THINK OUR CATHETERS ARE A MAJOR PART OF THIS ISSUE- I DON'T HAVE A COMPILATION OF WHICH 18G ARE THE PROBLEM BUT I WILL GET THAT OVER THE NEXT FEW WEEKS I JUST WANTED YOU AS OUR SUPPLY PERSON TO HEAR OF THE ISSUE. I AM UNSURE IF OTHERS ARE HAVING THIS SAW ISSUE BUT I HAVE INCLUDED THE PRACTICE COUNCIL ON THIS TO SEE IF THERE IS OTHER INPUT HOUSEWIFE (THOUGH MY MEMBERSHIP IS LIMITED SO I AM NOT SURE IF WE WILL GET OTHER INPUT). THANK YOU AND I WILL GET THE TALLIED LIST OF NUMBERS WHEN I CAN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573421 INSYTE AUTOGUARD GN 18GA X 1.16IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381444 SEE H.10. 30382903814443

    Patients

    Seq Age Sex Outcome Treatment
    1