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: 10405453 · Received August 13, 2020

    Report

    Report Number
    1710034-2020-00506
    Event Type
    Malfunction
    Date Received
    August 13, 2020
    Date of Event
    July 21, 2020
    Report Date
    October 6, 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
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SEVEN SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED THREE UNOPENED SAMPLES AND FOUR USED PARTIALLY RETRACTED UNITS. UPON INSPECTION OF THE RECEIVED UNITS, ALL FOUR OPENED UNITS AND TWO OF THE THREE UNOPENED UNITS HAD DAMAGE TO THE GRIP. THE GRIP WAS FOUND TO BE SLIGHTLY WARPED INWARD ACTING AS A STOP WHEN THE UNITS ARE RETRACTED. THE UNUSED RETURNED UNITS WERE TESTED FOR RETRACTION AND THE TWO UNITS WITH THE DEFECTIVE GRIP FAILED. THE UNIT WITH NO DEFECT RETRACTED AS EXPECTED. THE REPORTED ISSUE WAS CONFIRMED. THIS WAS PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING EQUIPMENT RELATED ISSUE FOR THE REPORTED DEFECT RELATING TO A POSSIBLE MISALIGNMENT OF THE PLUG PROBE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCE'S ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    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 DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE NEEDLES FAILED TO RETRACT. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: INJURIES OR ADVERSE EVENT: NO. MEDLINE REFERENCE. ITEM: 381412. QUANTITY AFFECTED: 5 BX. LOT NUMBER: 0080382. PO #: 4512896792. ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: THEY ARE NOT RETRACTING. CUSTOMER DISPOSITION REQUEST: REPLACEMENT".

    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 24 GA 0.75 IN (0.7 X 19 MM) HAD A NEEDLE THAT DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE NEEDLES FAILED TO RETRACT. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: INJURIES OR ADVERSE EVENT: NO. MEDLINE REFERENCE:, ITEM: 381412, QUANTITY AFFECTED: 5 BX, LOT NUMBER: 0080382, PO #: (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: THEY ARE NOT RETRACTING. CUSTOMER DISPOSITION REQUEST: REPLACEMENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869548 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