BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 24GAX0.75IN PRN SLM NPVC

    MDR report key: 20375923 · Received October 4, 2024

    Report

    Report Number
    3002601200-2024-00490
    Event Type
    Malfunction
    Date Received
    October 4, 2024
    Date of Event
    July 21, 2024
    Report Date
    September 11, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830787
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 4052015. 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. ADDITIONALLY A PHOTOGRAPH AND SAMPLE WERE SUBMITTED TO AID IN OUR INVESTIGATION. THE RETURNED PHOTOGRAPH DISPLAYS A LONG THREAD-LIKE ABNORMALITY ON THE SURFACE OF THE CATHETER TUBING. VISUAL ANALYSIS OF THE RETURNED DEVICE WAS NOT ABLE TO IDENTIFY THE SAME THREADLIKE ABNORMALITY, SUGGESTING THAT EITHER A SECONDARY DEVICE WAS SUBMITTED, OR THE OBSERVED ABNORMALITY WAS MOVABLE. THE NONCONFORMANCE OF FOREIGN MATERIAL WAS CONFIRMED. MICROSCOPIC INSPECTION OF THE CATHETER TUBING SURFACE IDENTIFIED A SMALL BUMP WHICH WAS IDENTIFIED AS EXCESS LUBRICANT AND NATIVE TO THE MANUFACTURING PROCESS. NO ADDITIONAL ABNORMALITIES WERE OBSERVED ON THE SURFACE OF THE CATHETER TUBING. WITHOUT THE ABILITY TO REVIEW THE REPORTED THREADLIKE PROTRUSION OUR ENGINEERS COULD NOT CONFIRM THAT IT WAS THE SAME MATERIAL AS THE LUBRICANT. EXCESS LUBRICATION IS OFTEN CAUSED BY BUILD UP DURING THE MANUFACTURING PROCESS. REGULAR CLEANING OF THE MACHINERY IS IN PLACE TO REMOVE ANY BUILD UP DURING THE MANUFACTURING PROCESS. TO PREVENT FUTURE OCCURRENCES OF THIS NONCONFORMANCE, OUR FACILITY HAS TIGHTENED THE INTERVALS BETWEEN CLEANINGS. WE REGRET ANY INCONVENIENCES THIS INCIDENT MAY HAVE CAUSED YOU AND YOUR FACILITY. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 24GAX0.75IN PRN SLM NPVC SILICONE VISIBLE ON NEEDLE / CATHETER CHECKED BEFORE USE, FOUND BURRS ON NEEDLE TIP, NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1402192 BD INTIMA-II 24GAX0.75IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4052015 00382903830787

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown