BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX® PORTEX® ULTRAPERC® SINGLE DILATOR KIT

    MDR report key: 8363634 · Received February 22, 2019

    Report

    Report Number
    3012307300-2019-00895
    Event Type
    Malfunction
    Date Received
    February 22, 2019
    Date of Event
    January 23, 2019
    Report Date
    June 26, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    15019315106750
    PMA / PMN Number
    K040014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: ONE USED DECONTAMINATED SAMPLE OF 007/910/680 BLU TRACHEOSTOMY TUBE 8.0MM S/ASSY 1/EA WAS RECEIVED IN PLASTIC BAG WITHOUT ITS ORIGINAL PACKAGING. THIS COMPONENT IS NOT INCLUDED IN REPORTED TRACHEOSTOMY TUBE KIT 100/562/000CZ. NO GUIDEWIRE NOR 14G NEEDLE WHICH IS DESCRIBED AS PROBLEMATIC AS PER COMPLAINT DESCRIPTION WERE RECEIVED. BASED ON COMPLAINT DESCRIPTION DOCTOR WANTED TO INSERT 008/108/781 GUIDEWIRE PACK TUBE INTO 005/078/190 NEEDLE AND CANNULA 14G WHICH IS NOT IN COMPLIANCE WITH PROCESS WHICH IS DESCRIBED IN IFU 004/005/245A (L6394 REV. 103). AS PER IFU (SECTION 11.2 - 11.6) GUIDEWIRE SHALL BE INSERTED INTO CANNULA - NOT DIRECTLY INTO NEEDLE. DHR REVIEW SUMMARY:FOLLOWING DHRS WERE REVIEWED: FINISH GOOD WORK ORDER 100/562/000CZ LOT 3710346, MANUFACTURING DATE 2018-10-19, QUANTITY 136PCS; GOOD INWARDS RECORDS FOR 005/078/190 NEEDLE AND CANNULA LOT 18E15B, 2000PCS RECEIVED IN JUNE 2018; GOOD INWARDS RECORDS FOR 008/108/781 GUIDEWIRE PACK TUBE LOT 276775, 2500PCS RECEIVED IN JUNE 2018; A REVIEW OF THE DEVICE HISTORY RECORDS SHOWS THERE WERE NO OBSERVATIONS RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCT. THE CUSTOMER REPORTED CONDITION WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT GUIDEWIRE WAS UNABLE TO BE INSERTED DURING PROCEDURE INTO THE 14G NEEDLE. NEW KIT WAS THEN USED TO RESOLVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155036 PORTEX® PORTEX® ULTRAPERC® SINGLE DILATOR KIT TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. 3710346 15019315106750

    Patients

    Seq Age Sex Outcome Treatment
    1