BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOG BC WING PNK 20GA X1.16IN

    MDR report key: 10075004 · Received May 20, 2020

    Report

    Report Number
    1710034-2020-00317
    Event Type
    Malfunction
    Date Received
    May 20, 2020
    Date of Event
    April 24, 2020
    Report Date
    June 16, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903826347
    PMA / PMN Number
    K110443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INSYTE AUTOG BC WING PNK 20GA X1.16IN CATHETER WAS DEFECTIVE. THIS WAS DISCOVERED ON 2 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 382634 BATCH NO.: 9212090. IT WAS REPORTED THAT THE CATHETER WOULD NOT ADVANCE INTO THE PATIENT'S VEIN BUT SPUN FREELY ON THE NEEDLE. COMMENTS: THIS IS THE DESCRIPTION OF THE PROBLEM THAT WAS ENTERED IN THE SAFE. 4 ATTEMPTS TOTAL WERE MADE TO OBTAIN AN IV SITE. 3 ATTEMPTS WITH NEW IV CATHETERS WERE UNSUCCESSFUL. THE PT'S VEINS WERE VISIBLE ON THE SURFACE OF SKIN WITHOUT APPLICATION OF TOURNIQUET. ALL THREE ATTEMPTS WITH THE NEW IV CATHETERS 1 X 18 GAUGE 2 X 20 GAUGE RESULTED IN FLASH, BUT CATHETER WOULD NOT ADVANCE, THE CATHETER SPUN FREELY ON THE NEEDLE, UPON TRYING TO ADVANCE THE NEEDLE & CATHETER CAUSED PUCKERING/DIMPLING OF THE SKIN AND VEIN AND SUBSEQUENTLY CAUSE THE VEIN TO BLOW. 1 ATTEMPT WITH OLD 18 GAUGE CATHETER SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE LOT #: 9212090, MEDICAL DEVICE EXPIRATION DATE: 2022-07-31, DEVICE MANUFACTURE DATE: 2019-07-31. 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 INSYTE AUTOG BC WING PNK 20GA X1.16IN CATHETER WAS DEFECTIVE. THIS WAS DISCOVERED ON 2 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 382634, BATCH NO.: 9212090. IT WAS REPORTED THAT THE CATHETER WOULD NOT ADVANCE INTO THE PATIENT'S VEIN BUT SPUN FREELY ON THE NEEDLE. COMMENTS: THIS IS THE DESCRIPTION OF THE PROBLEM THAT WAS ENTERED IN THE SAFE. 4 ATTEMPTS TOTAL WERE MADE TO OBTAIN AN IV SITE. 3 ATTEMPTS WITH NEW IV CATHETERS WERE UNSUCCESSFUL. THE PT'S VEINS WERE VISIBLE ON THE SURFACE OF SKIN WITHOUT APPLICATION OF TOURNIQUET. ALL THREE ATTEMPTS WITH THE NEW IV CATHETERS 1 X 18 GAUGE 2 X 20 GAUGE RESULTED IN FLASH, BUT CATHETER WOULD NOT ADVANCE, THE CATHETER SPUN FREELY ON THE NEEDLE, UPON TRYING TO ADVANCE THE NEEDLE & CATHETER CAUSED PUCKERING/DIMPLING OF THE SKIN AND VEIN AND SUBSEQUENTLY CAUSE THE VEIN TO BLOW. 1 ATTEMPT WITH OLD 18 GAUGE CATHETER SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537482 INSYTE AUTOG BC WING PNK 20GA X1.16IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 382634 SEE H.10 30382903826347

    Patients

    Seq Age Sex Outcome Treatment
    1 Other