BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDIATRIC ENDOTRACHEAL TUBE

    MDR report key: 5114406 · Received September 30, 2015

    Report

    Report Number
    9611710-2015-00169
    Event Type
    Malfunction
    Date Received
    September 30, 2015
    Report Date
    September 4, 2015
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K951697
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA TO CLARIFY EVENT DETAILS: A PICTURE WAS RECEIVED WITH THE COMPLAINT DEPICTING THE ET MARKINGS NOT BEING ACCURATE. 7CM MARKING IS ACTUALLY 6.5CM WHEN MEASURED WITH A RULER. THIS INFORMATION WAS NOT PROVIDED ON MDR MANUFACTURER REPORT NUMBER: 9611710-2015-00169. ADDITIONAL INFORMATION RECEIVED: A QUALITY INVESTIGATION WAS PERFORMED TO INCLUDE A BATCH REVIEW AND REVEALED THE PRINTING ON THE LABELLED ET TUBE WAS CORRECT. THE COMPLAINT SAMPLE IS NOT EXPECTED TO BE AVAILABLE. HOWEVER, BASED ON THE PICTURE PROVIDED BY THE CUSTOMER THE MARKINGS ARE NOT ACCURATE. AN INTERNAL NONCONFORMANCE WAS OPENED AND IS STILL PENDING. THIS COMPLAINT WILL REMAIN OPEN UNTIL THE COMPLETION OF THE INVESTIGATION. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN REQUESTED. HOWEVER, NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THE REPORT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ONE UNUSED ENDOTRACHEAL PLAIN TUBE OF I.D. 3.0MM FITTED WITH COLOR CODED PP CONNECTOR OF CORRESPONDING SIZE AND TUBE WAS MARKED AS PER UNOMEDICAL SPECIFICATION AND WORK ORDER#(B)(4). PRODUCT WAS RECEIVED IN SEALED PREPRINTED BLISTER PACK AND WAS CLOSELY EXAMINED. IT WAS OBSERVED THAT THE LENGTH OF THE PRINTING FROM TIP TO MARKING 7CM WHEN MEASURED FOUND WITHIN THE SPECIFICATION OF ( ±0.3CM). THE INTERNAL NONCONFORMANCE PREVIOUSLY REPORTED ON MDR MFR# 9611710-2015-00169 SUBMITTED ON 11/04/2015 IS NO LONGER APPLICABLE TO THIS COMPLAINT SINCE THE SAMPLE WAS RECEIVED AND WITHIN SPECIFICATIONS. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "[ENDOTRACHEAL TUBE (ETT] MARKINGS [WERE] NOT ACCURATE. FOR EXAMPLE, 7CM MARKING IS ACTUALLY 6.5CM WHEN MEASURED WITH RULER." IN ADDITION, THE ETT HAD NO MARKINGS BELOW 7CM, WHICH MADE IT DIFFICULT TO ESTIMATE LENGTH NEEDED TO ANCHOR ETT. FINALLY, THE ETT "[LEAKED] A LOT" AND [CAUSED] INACCURATE TIDAL VOLUME ON VENTILATOR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643749 PEDIATRIC ENDOTRACHEAL TUBE TUBE, TRACHEAL (W/WO CONNECTOR) BTR UNOMEDICAL SDN BHD MM61130030 618029R001

    Patients

    Seq Age Sex Outcome Treatment
    1