BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAMP CANNULA

    MDR report key: 11580219 · Received March 28, 2021

    Report

    Report Number
    3012307300-2021-02562
    Event Type
    Malfunction
    Date Received
    March 28, 2021
    Report Date
    May 26, 2021
    Product Code
    FKC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: NO PRODUCT WAS RETURNED. WE ARE UNABLE TO CONFIRM THE REPORTED COMPLAINT. IF THE PRODUCT IS RETURNED, SMITHS MEDICAL WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. NO OTHER ANALYSIS WAS PERFORMED. MITIGATION: IN HRA PER PWI-10011070 IS 100 PERCENT .VISUALLY CHECK THAT INFLATION LINE AND PILOT BALLOON IS NOT DAMAGED OR CONTAMINATED PER QP3027 QUALITY TAKES A SAMPLE USING AN AQL 0.15 AND LEVEL INSPECTIONS G-I IN ORDER TO VERIFY THE VISUAL INSPECTION AND AUDIT LEAK TEST. SAMPLES SIZE TO BE DETERMINED BASED ON THE EXPECTED LOT USING ANSI/ASQC Z1.4 PRODUCTION PERFORMS A 100 PERCENT IN PROCESS VISUAL INSPECTION, IN ORDER TO VERIFY THAT THE SUCTION TUBE IS COMPLETELY BONDED TO THE FLANGE. PRODUCTION PERFORMS A 100 PERCENT. IN PROCESS WEIGHT TEST TO THE BONDING BETWEEN THE SUCTION LINE AND THE FLANGE, IN ORDER TO ENSURE THAT NO DETACHMENT OCCURS BETWEEN THE FLANGE AND THE SUCTION LINE. QUALITY CONTROL EVERY 2 HOURS TAKES 13 PROCESSED UNITS, IN ORDER TO VERIFY THAT THE SUCTION TUBE IS COMPLETELY BONDED TO THE FLANGE. ROOT CAUSE: NO ROOT CAUSE COULD DETERMINATE SINCE THE COMPLAINT COULD NOT BE CONFIRMED SINCE NO SAMPLES OR PICTURES WERE RECEIVED OR ATTACHED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: B5: UPDATED WITH ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    NO PRODUCT RETURNED. SUMMARY FROM SME ON DEVICE ENGINEERING.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THAT THE BODY OF THE CANNULA BECAME DETACHED FROM THE COLLAR. THE TUBE REMAINED INSIDE THE PATIENT, BUT THE MOTHER DID NOT REALIZE IT, AND THEY TRIED TO INSTALL A NEW CANNULA BY PUSHING INSIDE THE PIECE OF THE FIRST CANNULA. THE PEDIATRIC PATIENT SUBSEQUENTLY UNDERWENT A SURGICAL OPERATION TO ADDRESS THE INCIDENT. NO FURTHER ADVERSE HEALTH EFFECTS WERE REPORTED IN RELATION TO THIS EVENT.

    Description of Event or Problem · 1

    CUSTOMER STATES "IT WORRIES US THAT THE POSSIBILITY OF THE CANNULA DETACHING LIKE WHAT HAPPENED A FEW YEARS AGO AT HOSPITAL (B)(6) IS STILL IN THE MEMORY OF PROFESSIONALS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477679 CLAMP CANNULA FKC

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening