BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA PRN BL 22GA X 0.75IN

    MDR report key: 19951227 · Received August 9, 2024

    Report

    Report Number
    3002601200-2024-00379
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    July 6, 2024
    Report Date
    August 16, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903833283
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DHR REVIEW: THE COMPLAINT LOT# IS 4052767, SKU IS (B)(6), ASSEMBLY IN SUZHOU PLANT ON 2024.MAR.7, LOT QUANTITY IS (B)(4). 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 PICTURE PROVIDED. RETAIN SAMPLE ANALYSIS: SAMPLING 2EA FROM THE RETAIN SAMPLE OF THE SAME LOT TO CHECK PRODUCT FUNCTION, PRODUCT SAFETY SHIELD ACTIVATION FUNCTION IS GOOD. REFER TO THE ATTACHMENT FOR RETAIN SAMPLE TEST REPORT. POSSIBLE CAUSE ANALYSIS: BASED ON THE REPORTED INFORMATION, NEEDLE IS EXPOSURE TO AIR. POSSIBLE REASONS FOR THIS TYPE OF FAILURE MAY INCLUDING: 1. THE ASSEMBLY STATUS BETWEEN OUTER SHIELD AND RUBBER IS NOT GOOD, THE RUBBER IS NOT PRESSED TO THE END DURING ASSEMBLY. 2. PRODUCT SAFETY SHIELD IS PULLED DURING MANUAL ASSEMBLY FLOW OR MANUAL PACKAGING. THESE RISK WILL CAUSE THE OUTER SHIELD DROPS OFF BEFORE THE NEEDLE RETRACTED COMPLETELY. CURRENT MANUFACTURE ALREADY HAS CONTROL PROCEDURES AS BELOW TO DEFECT AND PREVENT THIS KIND OF DEFECT: 1. 100% INSPECTION FOR THE GAP BETWEEN OUTER AND RUBBER IS PERFORMED AT THE LAST STATION OF ASSEMBLY 2. BOTH IN-PROCESS AND OUTGOING SAMPLING CHECK WILL TEST THE SEPARATION FORCE BETWEEN RUBBER AND OUTER SHIELD THERE IS NO DEFECT SAMPLE RETURNED, ALSO NO DEFECT SAMPLE PICTURE PROVIDED, WITHOUT THIS, WE CANNOT IDENTIFY THE ACTUAL DEFECT FEATURE, CANNOT DETERMINE WHETHER IT¿S A POOR ASSEMBLY ISSUE OR RAW MATERIAL ISSUE, SO THE ROOT CAUSE OF THIS CASE IS NOT CLEAR. BASED ON THE IFU DESCRIPTION, HOLD THE PULLER AND KEEP THE COMPONENT A DOWN CAN ACTIVATE NEEDLE SAFETY FUNCTION SUCCESSFULLY.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SAF-T-INTIMA PRN BL 22GA X 0.75IN SAFETY SHIELD ACTIVATION FAILED DATE: 08/07/2024 DESCRIPTION OF FACTS, CIRCUMSTANCES AND MEANS USED: AFTER PLACING THE INTIMA ON THE PATIENT, THE SAFETY GUIDE CONTAINING THE CANULA DID NOT LOCK INTO PLACE AND THE CANULA CAME OUT COMPLETELY (THIS EVENT OCCURRED TWICE IN THE MORNING) THIS CONCERNS BLUE INTIMA, I.E. 22GA FREQUENCY: 4-PROBABLE (1 TO 4 TIMES A MONTH) DESCRIPTION OF CONSEQUENCES: RISK OF AES +++ THE DEVICE WAS NOT KEPT BY THE CARE TEAM. THE ONLY ANSWER I CAN GIVE TO YOUR QUESTION IS THAT THE SAFETY SHIELD DIDN'T ACTIVATE ON 3 INTIMAS IN 2 DAYS, BUT I CAN'T TELL YOU MORE AS WE'RE USED TO USING THIS EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2247808 BD SAF-T-INTIMA PRN BL 22GA X 0.75IN INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4052767 00382903833283

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown