BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19892845 · Received August 2, 2024

    Report

    Report Number
    3002601200-2024-00368
    Event Type
    Malfunction
    Date Received
    August 2, 2024
    Date of Event
    July 8, 2024
    Report Date
    August 6, 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

    IN RESPONSE TO THE EVENT REPORTED BY YOUR FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 4052767. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS. UNFORTUNATELY, WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. BD WILL CONTINUE TO MONITOR THIS ISSUE AND ENCOURAGES YOU TO SUBMIT YOUR SAMPLE FOR REVIEW.

    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

    NO ADDITIONAL INFORMATION.

    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: (B)(6) 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740230 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