BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II Y 26GAX0.56IN SSPRN SLM NPVC

    MDR report key: 11311510 · Received February 10, 2021

    Report

    Report Number
    3006948883-2021-00218
    Event Type
    Malfunction
    Date Received
    February 10, 2021
    Date of Event
    January 14, 2021
    Report Date
    February 1, 2021
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED BY YOUR FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9233925. 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 OUR ENGINEERS HAVE EVALUATED THE RETURNED DEVICES UNDER A MICROSCOPE, BUT WERE NOT ABLE TO OBSERVE ANY DEFORMITIES, DAMAGE, OR NON-CONFORMANCES THAT COULD HAVE LEAD TO THIS EVENT. FURTHER FUNCTIONAL TESTING WAS ALSO UNABLE TO IDENTIFY ANY DEVIATIONS FROM PRODUCT SPECIFICATIONS. 10 RETURNED SAMPLES NOT USED WERE TAKEN FOR PENETRATION FORCE TEST, THE LIE DISTANCE, THE NEEDLE TIP, CATHETER TIP AND CATHETER DRAG FORCE MET THE PRODUCT SPECIFICATION. NEEDLE REMOVAL FORCE TEST ALSO MET THE PRODUCT REQUIREMENTS. THE NEEDLE TIP AND CATHETER TIP WERE OBSERVED UNDER THE MICROSCOPE AND NO ABNORMALITY OBSERVED. 2 RETAINED SAMPLES OF THIS LOT WERE TAKEN FOR PENETRATION FORCE TEST, THE LIE DISTANCE, THE NEEDLE TIP, CATHETER TIP AND CATHETER DRAG FORCE MET THE PRODUCT SPECIFICATION. NEEDLE REMOVAL FORCE TEST ALSO MET THE PRODUCT REQUIREMENTS. THE NEEDLE TIP AND CATHETER TIP WERE OBSERVED UNDER THE MICROSCOPE AND NO ABNORMALITY OBSERVED. INVESTIGATION CONCLUSION: THE PLANT WILL KEEP MONITOR THE DEFECTS. ROOT CAUSE DESCRIPTION: UNFORTUNATELY, WITHOUT THE ABILITY TO INVESTIGATE THE REPORTED ISSUE OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. RATIONALE: NO NEED FOR CAPA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTIMA-II Y 26GAX0.56IN SSPRN SLM NPVC NEEDLE WAS DIFFICULT TO WITHDRAW. THIS OCCURRED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN THE PROCESS OF PUNCTURING, IT WAS FELT BLUNT , AND IT WAS ALSO HARD TO WITHDRAW THE NEEDLE. 2021-1-15 RECEIVED AN UPDATE FROM THE SALES REPRESENTATIVE, AND THE EVENT DESCRIPTION WAS UPDATED AS FOLLOWS: IN THE SAME PATIENT, THERE WERE 3 CONTINUOUS CATHETER TUBING WITH VISIBLE SPIRAL TWISTS IN RUIMA-S. AFTER THE BLOOD RETURNED DURING THE PUNCTURE, THE ANGLE WAS LOWERED AND THE CATHETER COULD NOT BE DELIVERED. FINALLY, 24G FLYING Q WAS USED TO SUCCESSFULLY PUNCTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208113 INTIMA-II Y 26GAX0.56IN SSPRN SLM NPVC CATHETER FOZ BD (SUZHOU) 9233925

    Patients

    Seq Age Sex Outcome Treatment
    1