BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORT INTRODUCER KIT

    MDR report key: 19314361 · Received May 14, 2024

    Report

    Report Number
    3003419114-2024-00001
    Event Type
    Malfunction
    Date Received
    May 14, 2024
    Date of Event
    April 15, 2024
    Report Date
    July 24, 2024
    Manufacturer
    AMERICAN CONTRACT SYSTEM
    Product Code
    OKE
    UDI-DI
    00191072209733
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THIS EVENT WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT 10CC CONTROL SYRINGE IS PART NUMBER WEL1300-10CNTL. A SUPPLIER CORRECTIVE ACTION (SCAR) WAS SUBMITTED TO WELMED, INC. (THE SUPPLIER OF THE DEVICE) ON MAY 7, 2024. WELMED FDA REGISTRATION NUMBER IS 3005841027. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION AND RESPONSE BY THE SUPPLIER. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE 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 PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    BASED ON THE RESULTS OF THE INVESTIGATION, WE COULD CONFIRM THE FAILURE REPORTED BY THE PHOTOGRAPH PROVIDED. THE EVALUATION PROCESS FOR COMPONENTS SPECIFIES THAT EACH COMPONENT IS INSPECTED FOR ANY ABNORMALITIES DURING KIT ASSEMBLY. A DEVICE HISTORY RECORD EVALUATION WAS PERFORMED, THERE WERE NO NON-CONFORMANCES OR ISSUES NOTED DURING MANUFACTURE OF COMPLAINT LOT. THIS APPEARS TO BE AN ISOLATED INCIDENT WHERE THE ASSEMBLY TEAMMATE FAILED TO DETECT THE HAIR PRESENCE DURING VERIFICATION PROCESSES. BASED ON THE HAIR LOCATION, THE SYRINGE WAS LIKELY RECEIVED FROM THE MANUFACTURER WITH THE HAIR ATTACHED TO THE SYRINGE WHERE PISTON IS LOCATED. A SUPPLIER CORRECTIVE ACTION WAS ISSUED TO WELMED COMMUNICATING THE COMPLAINT. ASSEMBLY OPERATORS WERE ALERTED AND RETRAINED ON THE IMPORTANCE OF INSPECTION PROCESSES FOR QUALITY ASSURANCE. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21 CFR 803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    THERE IS FOREIGN MATERIAL IN PROCEDURE PACK. LIDOCAINE SYRINGE HAS A HAIR BETWEEN THE HANDLE AND THE SYRINGE PISTON. THE SITE THREW AWAY THE ENTIRE PACK, DESPITE HAVING MULTIPLE EXPENSIVE ITEMS IN IT. THE STERILE FIELD WAS COMPROMISED. THE SITE INDICATED THERE WAS A 20 MINUTE SURGICAL DELAY AS A RESULT OF INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514604 PORT INTRODUCER KIT PORT INTRODUCER KIT OKE AMERICAN CONTRACT SYSTEM 954241 00191072209733

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown