BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22GA

    MDR report key: 16463859 · Received March 1, 2023

    Report

    Report Number
    1710034-2023-00160
    Event Type
    Malfunction
    Date Received
    March 1, 2023
    Date of Event
    February 2, 2023
    Report Date
    April 14, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814237
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN; AWARENESS DATE 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.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. EXAMINATION OF THE ACTUAL PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22GA THE NEEDLE WOULD NOT RETRACT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED ISSUE: CUSTOMER REPORTED: WE'VE HAD SEVERAL INSTANCES WITH THE NEEDLE NOT RETRACTING.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22GA THE NEEDLE WOULD NOT RETRACT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED ISSUE: CUSTOMER REPORTED: WE'VE HAD SEVERAL INSTANCES WITH THE NEEDLE NOT RETRACTING. MATERIAL NO. - 381423, LOT NO.: 2179472 AND 2042992. IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLES ARE NOT RETRACTING. VERBATIM: MDS- HELLO, WE HAVE RECEIVED A QUALITY COMPLAINT ON PRODUCT SOLD TO OUR CUSTOMER. PLEASE CONTACT THE CUSTOMER AND CC CX AND CX ON ANY FUTURE COMMUNICATION. INJURIES OR ADVERSE EVENT: NO. ITEM: 381423. QUANTITY AFFECTED: 2 EA . SERIAL/LOT NUMBER: 2179472 & 2042992. PO : 4515753621. ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: CUSTOMER REPORTED: WE'VE HAD SEVERAL INSTANCES WITH THE NEEDLE NOT RETRACTING. CUSTOMER DISPOSITION REQUEST: CREDIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1142385 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22GA INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381423 2042992 00382903814237

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown