BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA PRN YEL 24GA X 0.75IN

    MDR report key: 19256569 · Received May 6, 2024

    Report

    Report Number
    3002601200-2024-00166
    Event Type
    Malfunction
    Date Received
    May 6, 2024
    Date of Event
    December 16, 2023
    Report Date
    May 23, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903833184
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DHR REVIEW: THE COMPLAINT LOT# IS 3083574, SKU IS 383318, ASSEMBLY IN SUZHOU PLANT ON (B)(6) 2023, 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. 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. THESS 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. COMPLETE 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 ADOWN 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

    NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SAF-T-INTIMA PRN YEL 24GA X 0.75IN SAFETY MECHANISM FAILURE IT WAS REPORTED BY THE CUSTOMER THAT BD SAF-T-INTIMA BUTTERFLY CLYSIS PLACED AND NEEDLE SAFETY DID NOT ENGAGE, LEAVING USED NEEDLE EXPOSED AND STAFF AT RISK. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. AHS MDIP REFERENCE NUMBER (ID): 36490 DATE OF INCIDENT (YYYY-MM-DD): 2023-12-16 SITE NAME/LOCATION: XXXXXX LEVEL OF HARM: NO APPARENT HARM - REACHED PATIENT/PERSON, CLOSE CALL AHS OPTIONAL REPORT TO CMDSNET (HEALTH CANADA): YES INCIDENT DETAILS: BD SAF-T-INTIMA BUTTERFLY CLYSIS PLACED AND NEEDLE SAFETY DID NOT ENGAGE, LEAVING USED NEEDLE EXPOSED AND STAFF AT RISK. DEVICE INFORMATION DEVICE NAME/DESCRIPTION: BD SAF-T-INTIMA 24G BUTTERFLY CLYSIS MANUFACTURER: BD DEVICE EXPIRY DATE (YYYY-MM-DD): UNKNOWN WAS THE DEVICE RETAINED? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621266 BD SAF-T-INTIMA PRN YEL 24GA X 0.75IN INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 3083574 00382903833184

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown