BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTERIAL CANNULA 20G/45MM

    MDR report key: 10841891 · Received November 15, 2020

    Report

    Report Number
    8041187-2020-00753
    Event Type
    Malfunction
    Date Received
    November 15, 2020
    Date of Event
    October 21, 2020
    Report Date
    January 6, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2020-11-24. H6: INVESTIGATION SUMMARY: SIX SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. ONE USED SAMPLE WAS RECEIVED FROM BATCH 9289215 AND FIVE REPRESENTATIVE SAMPLES WERE RECEIVED FROM 0113034. THE ACTUAL SAMPLE WAS SUBJECTED TO SIMULATION, BY PUMPING WATER MANUALLY TO CHECK FOR LEAKAGE. DURING THE SIMULATION, LEAKAGE WAS OBSERVED AT THE FLOSWITCH BUTTON AREA AND A COLLAPSE VALVE WAS OBSERVED ON THE LEAKAGE AREA. THE REPRESENTATIVE SAMPLES WERE SUBJECTED TO VISUAL INSPECTION AND LEAKAGE TESTING. ALL SAMPLES PASSED THIS TESTING AND NO COLLAPSE VALVE WAS OBSERVED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE PHOTO, THE DAMAGE ON THE SILICONE VALVE IS AT THE CATHETER BRUSH END. THE MOST PROBABLE ROOT CAUSE COULD BE DUE TO THE MISALIGNMENT OF THE ROTARY DRUM WITH THE PRE-INSERT PIN. WHEN MIS-ALIGNMENT OF THE ROTARY DRUM WITH THE PRE-INSERT PIN OCCURS, THE SILICONE VALVE WILL BE MIS-ALIGNED WITH THE FLOW SWITCH HOUSING DURING THE ASSEMBLY PROCESS. THE COLLAPSED VALVE MIGHT OCCUR WHEN THE SILICONE VALVE IS NOT SEATED PROPERLY AFTER BEING INSERTED INTO THE FLOW SWITCH HOUSING. FROM THE DEVICE HISTORY REVIEW, THERE WERE NO MACHINE RELATED ISSUES RECORDED FOR COLLAPSED VALVE AND LEAK TEST FAILURES. THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ARTERIAL CANNULA 20G/45MM PLUNGER LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER INSERTION THE RED PLUNGER IS LEAKING.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0113034, MEDICAL DEVICE EXPIRATION DATE: 2025-04-30, DEVICE MANUFACTURE DATE: 2020-04-22. MEDICAL DEVICE LOT #: 9289215, MEDICAL DEVICE EXPIRATION DATE: 2024-10-31, DEVICE MANUFACTURE DATE: 2019-10-16. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ARTERIAL CANNULA 20G/45MM PLUNGER LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER INSERTION THE RED PLUNGER IS LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1306864 ARTERIAL CANNULA 20G/45MM CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1