BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX BLUE LINE ULTRA SUCTIONAID

    MDR report key: 14137852 · Received April 18, 2022

    Report

    Report Number
    3012307300-2022-06557
    Event Type
    Injury
    Date Received
    April 18, 2022
    Date of Event
    March 11, 2022
    Report Date
    November 6, 2023
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    BTO
    UDI-DI
    15019315104862
    PMA / PMN Number
    K030570
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED ITEM 100/870/080CZ LOT 4121481 RECEIVED AT MMUC ITEM 100/810/085CZ LOT 3725972. CUSTOMER NOT ABLE TO VERIFY. DEVICE EVALUATION: ONE ORIGINAL SHELF CARTON 100/810/085CZ LOT 3725972 INCLUDING ONE NOT OPENED UNIT PACK WAS RECEIVED FOR INVESTIGATION (SEE PHOTO OF SAMPLE). UNIT PACK WAS OPENED AND IT WAS FOUND THAT INSIDE 8.5MM KIT 100/810/085CZ LOT 325972 THERE IS INCORRECT SIZE TRACHEOSTOMY TUBE. THERE WAS 007/910/675 BUT THERE SHOULD BE 007/910/685. FURTHERMORE INCORRECTLY PRINTED PATIENT LABEL 003/433/002 WAS FOUND INSIDE BLISTER. PATIENT LABEL WAS PRINTED AS 100/810/075CZ LOT 3717992 BUT IT SHOULD BE PRINTED AS 100/810/085CZ LOT 3725972. BASED ON THIS VISUAL INSPECTION COMPONENT MIXUP WAS CONFIRMED. PRODUCT SIZE MIXUP RESULTED TO REPORTED PROBLEM - 8.5MM INNER CANNULA CANNOT BE INSERTED INTO 7.5MM TRACHEOSTOMY TUBE. ANY OTHER CUSTOMER COMPLAINT WHICH IS DESCRIBING THE SAME ISSUE WITH 100/810/085CZ LOT 3725972 NOR 100/810/075CZ LOT 3717992 WAS RECEIVED. DUE TO FACT THAT INCORRECT COMPONENTS WERE FOUND INSIDE SEALED UNIT PACK THIS ISSUE IS CONSIDERED TO BE MANUFACTURING ERROR. COMPLAINT WAS ESCALATED TO NCR-001249 WHERE FURTHER INVESTIGATION AND ASSESSMENT WILL BE DOCUMENTED. FOLLOWING DHR REVIEW WAS PERFORMED: FINISH GOOD WORK ORDER 100/810/085CZ LOT 3725972, MANUFACTURING DATE 2018-11-05, QUANTITY 416PCS. DURING MANUFACTURING OF THIS BATCH NCMR1656 WAS RAISED DUE TO INNER CANNULA CONTAMINATION. WHOLE WORK ORDER WAS 100% REINSPECTED AND NON-CONFORMING PIECES WERE REWORKED (RE-PACKED). THERE IS NO RECORD WITHIN DHR WHICH INDICATES THAT MIXUP MIGHT HAPPEN DURING MANUFACTURING. FINISH GOOD WORK ORDER 100/810/075CZ LOT 3717992, MANUFACTURING DATE 2018-11-06, QUANTITY 911PCS. DURING MANUFACTURING OF THIS BATCH NCMR1652 WAS RAISED DUE TO LOOSE PARTICLE IN FINISH GOOD KIT. WHOLE WORK ORDER WAS 100% REINSPECTED AND NON-CONFORMING PIECES WERE SCRAPPED. THERE IS NO RECORD WITHIN DHR WHICH INDICATES THAT MIXUP MIGHT HAPPEN DURING MANUFACTURING. BASED ON DHR RECORDS THOSE TWO WORK ORDERS WERE PACKED THE SAME DAY 09-NOV-2018 ON PACKAGING MACHINE ULMA. THE SAME DAY BLISTERS WHICH WERE REJECTED DURING PACKAGING WERE REPACKAGED (RE-DO PROCESS). IT IS THE MOST PROBABLE THAT MIXUP HAPPENED 09-NOV-2018 DURING PACKAGING PROCESS OR DURING RE-DO PROCESS. BASED ON DHR RECORDS LINE CLEARANCE (CZHDP4008) WAS PERFORMED ON THOSE TWO WORK ORDERS BY THE SAME OPERATOR - (B)(4) . PACKAGING OF THOSE TWO WORK ORDERS WAS DONE ALSO BY THE SAME OPERATORS - (B)(4) . CUSTOMER ALSO MENTIONED PRODUCT 100/870/080CZ LOT 4121481 BUT THIS PRODUCTS DOES NOT SEEM TO BE RELATED TO THIS CUSTOMER COMPLAINT - ITS PACKAGING WAS DONE IN DIFFERENT TIME PERIOD (MAY 2021) AND ANYTHING RELATED TO 8.0MM SIZE WAS RECEIVED.

    Additional Manufacturer Narrative · 0

    H1 CORRECTED FROM MALFUNCTION TO SERIOUS INJURY REPORTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INNER CANNULA CANNOT LOCK IN THE TRACHEOSTOMY TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2627372 PORTEX BLUE LINE ULTRA SUCTIONAID TUBE, TRACHEAL (W/WO CONNECTOR) BTO SMITHS MEDICAL INTERNATIONAL, LTD. 100/870/080CZ 3725972 15019315104862

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention