BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    FLEX EXTENDERS

    MDR report key: 20206989 · Received September 12, 2024

    Report

    Report Number
    2028807-2024-00031
    Event Type
    Malfunction
    Date Received
    September 12, 2024
    Date of Event
    August 14, 2024
    Report Date
    October 28, 2024
    Manufacturer
    WESTMED LLC
    Product Code
    CAI
    UDI-DI
    10709078008402
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. THE DEVICE HISTORY RECORD FOR LOT 0004290328 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 12 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

    PRODUCT WAS RETURNED BY THE REPORTER FOR EVALUATION, IT WAS NOTED, DURING EVALUATION SETUP TWO OF THE CONNECTORS FELL OUT AND DURING TESTING IT WAS FOUND THAT THE CONNECTION FORCE WAS BELOW SPECIFICATION. VISUAL EXAMINATION OF THE DRAWINGS IDENTIFIED THE CONNECTOR ON THE RETURNED PRODUCT DID NOT HAVE THE RETAINING RING AND THE ABSENCE OF THE RETAINING RING RESULTED IN A POOR CONNECTION FORCE BETWEEN THE CONNECTORS AND THE FLEX TUBE. THE REPORTED EVENT COULD BE CONFIRMED AS REPORTED; THE ROOT CAUSE IS RELATED TO MANUFACTURING. ALL INFORMATION REASONABLY KNOWN AS OF 28 OCT 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

    SUN MED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. AS NO SPECIFIC PATIENT OR PROCEDURE IDENTIFYING INFORMATION WAS PROVIDED, THIS REPORT WILL DOCUMENT BOTH INCIDENTS. IT WAS REPORTED, THE PRODUCT NOW APPEARS TO COME IN 2 PIECES AND A CLEAR PIECE BECAME DISLOGDGED TWICE (IN THE MIDDLE OF TWO CASES); THERE WAS NO REPORTED INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE PRODUCT NOW APPEARS TO COME IN 2 PIECES AND A CLEAR PIECE BECAME DISLODGED TWICE, IN THE MIDDLE OF TWO CASES; THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1592347 FLEX EXTENDERS FLEX EXTENDERS 5.2 X 15MM X 22MM X 15MM CAI WESTMED LLC 7-5132 0004290328 10709078008402

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown