BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX EXTENDERS

    MDR report key: 20252007 · Received September 18, 2024

    Report

    Report Number
    2028807-2024-00041
    Event Type
    Malfunction
    Date Received
    September 18, 2024
    Report Date
    November 4, 2024
    Manufacturer
    WESTMED LLC
    Product Code
    CAI
    UDI-DI
    00709078008405
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 18 SEP 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED BY THE CUSTOMERS FOR EVALUATION. TESTING OF THE SAMPLE REVEALED DURING SET UP, TWO OF THE CONNECTORS FELL OUT; THE CONNECTION FORCE WAS FOUND TO BE BELOW SPECIFICATION. ADDITIONALLY, THE DRAWINGS WERE INSPECTED AND IT WAS DETERMINED THE CONNECTOR, ON THE RETURNED PRODUCT, DID NOT HAVE THE RETAINING DRAWINGS, WHICH RESULTED IN A POOR CONNECTION FORCE BETWEEN THE CONNECTORS AND THE FLEX TUBE. THE REPORTED EVENT COULD BE CONFIRMED AS REPORTED; THE ROOT CAUSE WAS TRACED TO THE MANUFACTURING PROCESS. ALL INFORMATION REASONABLY KNOWN AS OF 04 NOV 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT-(B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE FOURTH OF FOUR REPORTS. REFER TO 2028807-2024-00033 FOR THE FIRST REPORT. REFER TO 2028807-2024-00039 FOR THE SECOND REPORT. REFER TO 2028807-2024-00040 FOR THE THIRD REPORT. IT WAS REPORTED, THE NEW CLEAR PLASTIC PIECE EASILY CAME OFF OF THE FLEX EXTENDER(S) AND CREATED A DISCONNECT BETWEEN THE PATIENT(S) AND THE VENTILATOR. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED, 21AUG2024 REPORTED, A NONSERIOUS INJURY WAS NOTED WHEN THE FLEX EXTENDER DISCONNECTED DURING MECHANICAL VENTILATION

    Description of Event or Problem · 0

    SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE FOURTH OF FOUR REPORTS. REFER TO 2028807-2024-00033 FOR THE FIRST REPORT. REFER TO 2028807-2024-00039 FOR THE SECOND REPORT. REFER TO 2028807-2024-00040 FOR THE THIRD REPORT. IT WAS REPORTED, THE NEW CLEAR PLASTIC PIECE EASILY CAME OFF OF THE FLEX EXTENDER(S) AND CREATED A DISCONNECT BETWEEN THE PATIENT(S) AND THE VENTILATOR. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED, 21AUG2024 REPORTED, A NONSERIOUS INJURY WAS NOTED WHEN THE FLEX EXTENDER DISCONNECTED DURING MECHANICAL VENTILATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1809498 FLEX EXTENDERS FLEX EXTENDERS 5.2 CAI WESTMED LLC 7-5132 004289133 00709078008405

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown