BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I

    MDR report key: 18567950 · Received January 23, 2024

    Report

    Report Number
    3014704491-2024-00031
    Event Type
    Malfunction
    Date Received
    January 23, 2024
    Date of Event
    January 9, 2024
    Report Date
    February 28, 2024
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    30382903833130
    PMA / PMN Number
    K923702
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DHR REVIEW: THE COMPLAINT LOT# IS 3171205, SKU IS 383313, ASSEMBLY IN SUZHOU PLANT ON 2023.JUN.26, LOT QUANTITY IS 24066EA REVIEW THE IN PROCESS TEST RECORD AND OUTGOING TEST REPORT, ALL TEST RESULTS MEET THE PRODUCT SPECIFICATIONS, NO ABNORMAL FOUND. REVIEW THE PRODUCT ASSEMBLY RECORD, NO NON-CONFORMITIES, DEVIATIONS OR REWORK ACTIVITIES FOR THIS LOT RETURNED SAMPLE ANALYSIS: NO RETURNED SAMPLE WAS SENT BACK, NO PHOTOS PROVIDED RETAIN SAMPLE ANALYSIS: SAMPLING 2EA FROM THE RETAIN SAMPLE OF THE SAME LOT TO CHECK NEEDLE AND CATHETER ASSEMBLY STATUS, CHECK LIE DISTANCE, ALL TEST RESULTS ARE WITHIN PRODUCT SPECIFICATION. REFER TO THE ATTACHMENT FOR RETAIN SAMPLE TEST REPORT. POSSIBLE CAUSE ANALYSIS: BASED ON THE REPORTED INFORMATION, LIE DISTANCE IS INCORRECT. POSSIBLE REASONS FOR THIS TYPE OF FAILURE MAY INCLUDING: 1. LIE DISTANCE SETTING IS NOT CORRECT DURING ASSEMBLY 2. LIE DISTANCE IS CHANGED DURING THE FOLLOWING MANUAL ASSEMBLY FLOW OR MANUAL PACKAGING AFTER LIE DISTANCE PRECISE SETTING CURRENT MANUFACTURE ALREADY HAS CONTROL PROCEDURES AS BELOW TO DETECT AND PREVENT THIS KIND OF DEFECT: 1. 100% INSPECTION FOR LIE DISTANCE DURING ALL PROCESS STATION AFTER LIE DISTANCE PRECISE SETTING 2. BOTH IN-PROCESS AND OUTGOING SAMPLING CHECK WILL INSPECT LIE DISTANCE THERE IS NO DEFECT SAMPLE RETURNED, NO PHOTOS PROVIDED AS WELL, THE RETAIN SAMPLE CHECK RESULTS ARE ALL WITHIN PRODUCT SPECIFICATIONS. WITH THE DESCRIBED INFORMATION WE CANNOT IDENTIFY THE ROOT CAUSE FOR THIS CASE.

    Additional Manufacturer Narrative · 0

    H.3. 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 · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED ITEM#383313 LOT#3171205.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SAF-T-INTIMA BENT IN HALF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BD SAF-T-INTIMA HAD A DEFECTIVE CATHETER. ATTEMPTED TO ADVANCE INTO VEIN, GREAT BLOOD FLOW BUT THE PLASTIC BENT IN HALF. STILL HAD SALINE AND BLOOD FLOW IN AND OUT BUT DIDN'T TRUST THAT IT WOULD NOT CAUSE CONTAMINATION OF THE RADIOTRACER I NEEDED TO INJECT. SET NEW LINE FOR INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1889336 BD SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 3171205 30382903833130

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown