BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE-N AUTOGUARD YEL 24GA X .56IN

    MDR report key: 12468763 · Received September 14, 2021

    Report

    Report Number
    1710034-2021-00805
    Event Type
    Malfunction
    Date Received
    September 14, 2021
    Date of Event
    August 17, 2021
    Report Date
    October 6, 2021
    Product Code
    FOZ
    UDI-DI
    30382903814122
    PMA / PMN Number
    K952861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD INSYTE-N AUTOGUARD YEL 24GA X .56IN HAD A HOLE IN IT THAT BLOOD LEAKED FROM DURING THE INSERTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "JUST YESTERDAY WHEN I WAS INSERTING AN IV WITH A STAFF MEMBER, THE CATHETER HAD A HOLE IN IT THAT BLOOD FLOWED OUT OF ON INSERTION WHICH RESULTED IN US HAVING TO POKE A SECOND TIME.". D2: MEDICAL DEVICE BRAND NAME: INSYTE-N AUTOGUARD YEL 24GA X .56IN. D4: LOT # 381411. D4: UDI # (B)(4). G.5. PMA / 510(K)#: K952861. D4: MEDICAL DEVICE EXPIRATION DATE: 2024-01-31. H4: DEVICE MANUFACTURE DATE: 2021-02-01. THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-09-15. H6: INVESTIGATION SUMMARY. BD RECEIVED A 24 GAUGE INSYTE-N AUTOGUARD CATHETER FROM LOT 1032423 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNIT BUT OBSERVED NO DAMAGE TO THE DEVICE. HOWEVER, A LEAKAGE TEST WAS THEN PERFORMED DUE TO THE REPORTS OF LEAKAGE BY THE USER. LEAKAGE WAS OBSERVED COMING FROM THE HALFWAY POINT IN THE CATHETER TUBING. MICROSCOPIC INSPECTION DETERMINED THAT THERE WAS A V-SHAPED CUT IN THE CATHETER TUBING. THIS CUT WAS INDICATIVE OF THE NEEDLE PIERCING THROUGH THE CATHETER TUBING. BASED OFF THE VISUAL INSPECTION THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. UNFORTUNATELY, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE-N AUTOGUARD YEL 24GA X .56IN HAD A HOLE IN IT THAT BLOOD LEAKED FROM DURING THE INSERTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "JUST YESTERDAY WHEN I WAS INSERTING AN IV WITH A STAFF MEMBER, THE CATHETER HAD A HOLE IN IT THAT BLOOD FLOWED OUT OF ON INSERTION WHICH RESULTED IN US HAVING TO POKE A SECOND TIME.".

    Additional Manufacturer Narrative · 1

    MEDICAL 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER HAD A HOLE IN IT THAT BLOOD LEAKED FROM DURING THE INSERTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "JUST YESTERDAY WHEN I WAS INSERTING AN IV WITH A STAFF MEMBER, THE CATHETER HAD A HOLE IN IT THAT BLOOD FLOWED OUT OF ON INSERTION WHICH RESULTED IN US HAVING TO POKE A SECOND TIME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1365521 INSYTE-N AUTOGUARD YEL 24GA X .56IN INTRAVASCULAR CATHETER FOZ 381412 1032423 30382903814122

    Patients

    Seq Age Sex Outcome Treatment
    1