BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    DISPOSABLE ANESTHESIA CIRCUIT

    MDR report key: 20232773 · Received September 16, 2024

    Report

    Report Number
    2028807-2024-00032
    Event Type
    Malfunction
    Date Received
    September 16, 2024
    Date of Event
    August 20, 2024
    Report Date
    September 19, 2024
    Manufacturer
    WESTMED LLC
    Product Code
    OFP
    UDI-DI
    00709078006081
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION:H2 CORRECTION: B5- IN THE INITIAL MEDWATCH REPORT, WHICH SUN MED HOLDINGS LLC. SUBMITTED TO THE FDA, ON 16SEP2024, H2 WAS INCORRECTLY SELECTED AND NOTED AS BEING THE SUMMARIZATION OF 5 REPORTED INCIDENTS. HOWEVER, BASED ON THE FOLLOW-UP INFORMATION PROVIDED BY THE REPORTER, THE EXACT NUMBER OF INCIDENTS IS UNKNOWN AND WILL THEREFORE; BE SELECTED AS 3 INCIDENTS. REFER TO 2028807-2024-00045 FOR THE SECOND REPORT . REFER TO 2028807-2024-00046 FOR THE THIRD REPORT . THE ACTUAL COMPLAINT PRODUCT WAS NOT AVAILABLE FOR RETURN; HOWEVER, THE REPORTER PROVIDED A PHOTOGRAPH OF THE ALLEGED DEVICE. BASED ON THE PROVIDED PHOTOGRAPH, THE EVENT WAS CONFIRMED AS REPORTED, THE BLUE TUBING CONNECTOR FELL OFF; HOWEVER, WITHOUT A SAMPLE TO PERFORM FUNCTIONAL EVALUATION THE ROOT CAUSE CANNOT BE DETERMINED. THE DEVICE HISTORY RECORD FOR LOT 475659 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 19 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 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 ACTUAL COMPLAINT PRODUCT WAS NOT AVAILABLE FOR RETURN; HOWEVER, THE REPORTER PROVIDED A PHOTOGRAPH OF THE ALLEGED DEVICE. BASED ON THE PROVIDED PHOTOGRAPH, THE EVENT WAS CONFIRMED AS REPORTED, THE BLUE TUBING CONNECTOR FELL OFF; HOWEVER, WITHOUT A SAMPLE TO PERFORM FUNCTIONAL EVALUATION THE ROOT CAUSE CANNOT BE DETERMINED. THE DEVICE HISTORY RECORD FOR LOT 475659 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 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 THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 2028807-2024-00045 FOR THE SECOND REPORT . REFER TO 2028807-2024-00046 FOR THE THIRD REPORT . IT WAS REPORTED, THE BLUE TUBING CONNECTOR FELL OFF, DURING PATIENT USE; THERE WAS NO REPORTED INJURY..

    Description of Event or Problem · 0

    SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. AS NO SPECIFIC PATIENT OR PROCEDURE IDENTIFYING INFORMATION WAS PROVIDED, THIS REPORT WILL DOCUMENT THE FIVE INCIDENTS. IT WAS REPORTED, THE BLUE TUBING CONNECTOR FELL OFF; THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1901385 DISPOSABLE ANESTHESIA CIRCUIT ANESTHESIA CIRCUIT, ADULT, 120 EXPANDABLE PARALLEL WYE, GSE, CLEAR, 2L LATEX OFP WESTMED LLC 9362 475659 00709078006081

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown