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: 10577985 · Received September 23, 2020

    Report

    Report Number
    1710034-2020-00612
    Event Type
    Malfunction
    Date Received
    September 23, 2020
    Date of Event
    September 2, 2020
    Report Date
    October 15, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814122
    PMA / PMN Number
    K952861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 9/10/2020. H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLES AND PHOTOGRAPH SUBMITTED FOR EVALUATION. BD RECEIVED FIVE SEALED UNITS, ONE UNIT IN AN OPENED PACKAGE, AND ONE EMPTY OPENED PACKAGE FROM REF. 381412, LOT 0080382, AS WELL AS ONE PHOTO. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. DURING THE VISUAL/MICROSCOPIC EXAMINATION OF THE PARTIALLY RETRACTED UNIT, IT WAS OBSERVED THAT THERE WAS DAMAGE TO THE GRIP. THE RETRACTION TEST WAS CONDUCTED WHICH CONSISTED OF REPOSITIONING THE UNIT TO THE OUT POSITION AND THEN DEPRESSING THE BUTTON. THE OBSERVED DAMAGE PREVENTED SUCCESSFUL RETRACTION, CONFIRMING YOUR REPORTED DEFECT. THE UNOPENED UNITS WERE VISUALLY INSPECTED AND RETRACTION WAS PERFORMED. NO DAMAGE WAS OBSERVED AND ALL FIVE UNITS SUCCESSFULLY RETRACTED. BASED ON THE EVIDENCE, THE DAMAGE LIKELY OCCURRED DUE TO MISALIGNMENT DURING THE MANUFACTURING PROCESS. 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) HAD A NEEDLE THAT WOULDN'T RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE NEEDLE FAILED TO FULLY RETRACT. COMPLAINT 2 OF 2: THIS PR REFLECTS THE 24G. THIS IS THE SECOND NEEDLE THIS WEEK THAT DID NOT FULLY RETRACT. I WANTED PEOPLE TO BE AWARE SO NO ONE GETS STUCK ACCIDENTALLY THINKING IT IS SAFE3. NANCY WOGER RECEIVED ANOTHER INSTYE THAT FAILED TO RETRACT THE NEEDLE. THE NURSE COMPLETED A MIDAS REPORT. INSTYE 24 GA. X 0.75 IN. LOT # (01)003829003814121. 381423 22G X 1¿ INSTYLE AUTOGARD LOT # 0122384. 381412 24G X ¾¿ INSTYLE AUTOGARD LOT # 0080382. THE ISSUE DOES NOT CAUSE HARM OR CHANGE THE TREATMENT OF THE PATIENT. IT IS A SAFETY CONCERNS FOR THE STAFF AS THE NEEDLE DOES NOT RETRACT FULLY AFTER IT IS ENGAGED."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 24GA 0.75IN (0.7 X 19 MM) HAD A NEEDLE THAT WOULDN'T RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE NEEDLE FAILED TO FULLY RETRACT. COMPLAINT 2 OF 2: THIS PR REFLECTS THE 24G. THIS IS THE SECOND NEEDLE THIS WEEK THAT DID NOT FULLY RETRACT. I WANTED PEOPLE TO BE AWARE SO NO ONE GETS STUCK ACCIDENTALLY THINKING IT IS SAFE3. NANCY WOGER RECEIVED ANOTHER INSTYE THAT FAILED TO RETRACT THE NEEDLE. THE NURSE COMPLETED A MIDAS REPORT. INSTYE 24 GA. X 0.75 IN LOT # (01)003829003814121 381423 22G X 1¿ INSTYLE AUTOGARD LOT # 0122384, 381412 24G X ¾¿ INSTYLE AUTOGARD LOT # 0080382. THE ISSUE DOES NOT CAUSE HARM OR CHANGE THE TREATMENT OF THE PATIENT. IT IS A SAFETY CONCERNS FOR THE STAFF AS THE NEEDLE DOES NOT RETRACT FULLY AFTER IT IS ENGAGED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042577 BD INSYTE AUTOGUARD SHIELDED IV CATHETER 24GA 0.75IN (0.7 X 19 MM) INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381412 0080382 30382903814122

    Patients

    Seq Age Sex Outcome Treatment
    1 Other