BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA Y ADP BL 22GA X 0.75IN ROW

    MDR report key: 20888152 · Received December 9, 2024

    Report

    Report Number
    3002601200-2024-00715
    Event Type
    Malfunction
    Date Received
    December 9, 2024
    Date of Event
    November 12, 2024
    Report Date
    February 3, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903833290
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    "DHR REVIEW: THE COMPLAINT LOT# IS 4081442, SKU IS 383329, ASSEMBLY IN SUZHOU PLANT ON 2024.APR.23, LOT QUANTITY IS 48066EA 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: TWO PICTURES ARE PROVIDED AND SHOW THE MANUFACTURE INFORMATION AND PRN ASSEMBLY STATUS, NO ABNORMAL OBSERVED WITH THIS PICTURE RETAIN SAMPLE ANALYSIS: SAMPLING 2EA FROM THE RETAIN SAMPLE OF THE SAME LOT TO CHECK NEEDLE RETRACTION FUNCTION AND FLASH BACK FUNCTION, ALL TEST RESULTS ARE WITHIN PRODUCT SPECIFICATION. REFER TO THE ATTACHMENT FOR RETAIN SAMPLE TEST REPORT. POSSIBLE CAUSE ANALYSIS: THE POSSIBLE REASON FOR NEEDLE RETRACTION FAILURE IS NEEDLE LUBRICATION IS NOT GOOD. PREVENTIVE CONTROL ACTION DURING MANUFACTURE AS BELOW HAVE BEEN TAKEN FOR THIS TYPE OF DEFECT: 1. NEEDLE RETRACTION IS REQUESTED DURING LIE DISTANCE ADJUSTING, POOR LUBRICATION SAMPLE CAN BE IDENTIFIED 2. IN-PROCESS AND OUTGOING SAMPLING CHECK WILL TEST NEEDLE RETRACT FORCE THE POSSIBLE REASON FOR BLOOD BACKS UP ISSUE IS: 1. FM IN CANNULA 2. STYLET/CANNULA CRIMPING POSITION IS WRONG PREVENTIVE CONTROL ACTION DURING MANUFACTURE AS BELOW HAVE BEEN TAKEN FOR THIS TYPE OF DEFECT: 1. 100% INSPECTION IS PERFORMED FOR INCOMING NEEDLE, NEEDLE CLOG ISSUE CAN BE DETECTED AND WILL BE SCRAPPED 2. BOTH IN-PROCESS AND OUTGOING SAMPLING CHECK WILL TEST PRODUCT FLASH BACK FUNCTION IN SUMMARY FOR THIS CASE, THE PICTURES ATTACHED CANNOT SHOW THE TYPICAL DEFECT FEATURE AS REPORTED, WE CANNOT IDENTIFY THE ACTUAL DEFECT MODE AND ANALYSIS IS FOR POSSIBLE REASONS. THE RETAINED SAMPLE ANALYSIS DOES NOT DETECT SIMILAR DEFECT, AND NO SIMILAR DEFECT COMPLAINT HISTORY RECORDED. WITH THIS THE ROOT CAUSE FOR THIS CASE IS NOT CLEAR".

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    A TRAINED EXPERIENCED NURSE HAS FACED DIFFICULTIES DRAWING BACK THE SAFETY MECHANISM AND THE PATIENTS BLOOD DOESN'T COME BACK TO THE EXTENSION OF THE CATHETER SYSTEM. AS A RESULT THE VEIN OF THE PATIENT IS BROKEN AND IV ACCESS IS NOT POSSIBLE. THE SAME INCIDENT HAPPENED IN AT LEAST 5 DIFFERENT PATIENTS , WITH CATHETERS FROM THE SAME BOX.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SAF-T-INTIMA Y ADP BL 22GA X 0.75IN ROW SAFETY MECHANISM / NEEDLE DISENGAGMENT DIFFICULT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A TRAINED EXPERIENCED NURSE HAS FACED DIFFICULTIES DRAWING BACK THE SAFETY MECHANISM AND THE PATIENTS BLOOD DOESN'T COME BACK TO THE EXTENSION OF THE CATHETER SYSTEM. AS A RESULT THE VEIN OF THE PATIENT IS BROKEN AND IV ACCESS IS NOT POSSIBLE. THE SAME INCIDENT HAPPENED IN AT LEAST 5 DIFFERENT PATIENTS , WITH CATHETERS FROM THE SAME BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2536307 BD SAF-T-INTIMA Y ADP BL 22GA X 0.75IN ROW INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4081442 00382903833290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown