BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUBING O2 50FT VNL TP W/CRUSH RES 15/CS

    MDR report key: 5781355 · Received July 9, 2016

    Report

    Report Number
    8030673-2016-00180
    Event Type
    Injury
    Date Received
    July 9, 2016
    Date of Event
    May 15, 2016
    Report Date
    June 10, 2016
    Manufacturer
    CAREFUSION/BD
    Product Code
    BYX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTABLE EVENT WAS SUBMITTED AS A MALFUNCTION. UPON FURTHER REVIEW CAREFUSION/ BD WILL BE REPORTING THIS INCIDENT AS AN ADVERSE EVENT REQUIRING INTERVENTION. THE PRODUCT CODE AND DEVICE CODE HAS BEEN CORRECTED. THE CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION. "THE HOSE WAS PUT IN SERVICE THE EVENING BEFORE THE KINK WAS DISCOVERED". THE CUSTOMER CONFIRMED THAT THERE WAS AN ADEQUATE SERVICE LOOP. THE PATIENTS HEALTH HISTORY INCLUDES CPOD THIS IS WHY SHE REQUIRES OXYGEN AT NIGHT. HER AVERAGE PULSE OX IS IN THE LOW 90'S. THE KINK WAS DISCOVERED WHEN THE PATIENTS PULSE OX DROPPED TO 82%. ONCE THE TUBING WAS CHANGED OUT THE PATIENT DID RECOVER BACK TO BASELINE. (B)(4). CAREFUSION/BD WAS UNABLE TO REVIEW THE DEVICE HISTORY RECORD; THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. ONE SAMPLE WAS RECEIVED FOR EVALUATION, DURING VISUAL INSPECTION A MARK WAS OBSERVED ON THE TUBE, CONFIRMING THE KINK CONDITION. UPON REVIEW OF THE MANUFACTURING PROCEDURE CAREFUSION/BD FOUND THE CORRECT ASSEMBLY INSTRUCTION BETWEEN THE TUBE AND THE END CONNECTORS; HOWEVER THE KINKED CONDITION ON TUBE IS LIKELY RELATED TO THE WAY THE CODE IS COILED. THIS PROCESS IS NOT CLEARLY DEFINED THE MANUFACTURING PROCEDURE HAS BEEN UPDATED TO SPECIFY HOW TO COIL THE FINISHED GOOD FOR PACKAGING AND SHIPPING.

    Additional Manufacturer Narrative · 1

    (B)(4). CAREFUSION HAS REACHED OUT TO CUSTOMER TO PROVIDE THE COMPLAINT DEVICE FOR FURTHER INVESTIGATION. THE CUSTOMER INDICATED THAT THE SAMPLE WAS SHIPPED BACK TO CAREFUSION, ALONG WITH ADDITIONAL WRITTEN DETAILS REGARDING THE REPORTED EVENT. A FOLLOW UP MDR WILL BE SENT ONCE THE INVESTIGATION HAS BEEN COMPLETED. (B)(4).

    Description of Event or Problem · 1

    THERE WAS A KINK IN THE HOSE, THEREFORE, NO OXYGEN WAS RECEIVED PER THE PATIENT. END-USER STATED THAT HIS WIFE HAS MULTIPLE HEALTH PROBLEMS AND WILL LIKELY BE READMITTED WITH RESPIRATORY ISSUES. HE IS UNSURE IF HER DROWSINESS WAS RELATED TO HER MEDICAL CONDITION, OR THE REPORTED KINKED TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435207 TUBING O2 50FT VNL TP W/CRUSH RES 15/CS TUBING, PRESSURE AND ACCESSORIES BYX CAREFUSION/BD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention