BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH LAB PACK

    MDR report key: 21514314 · Received March 4, 2025

    Report

    Report Number
    3008492337-2025-00001
    Event Type
    Malfunction
    Date Received
    March 4, 2025
    Date of Event
    February 11, 2025
    Report Date
    May 6, 2025
    Manufacturer
    AMERICAN CONTRACT SYSTEMS, INC.
    Product Code
    OES
    UDI-DI
    00191072178404
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLES WERE AVAILABLE FOR RETURN. MEDLINE (THE SUPPLIER OF COMPONENT) WAS ABLE TO CONFIRM ISSUE BASED ON PROVIDED PHOTO. KIT DEVICE HISTORY RECORD WAS REVIEWED, ALL APPROVALS AND INSPECTIONS WERE COMPLETED. NO QUALITY NONCONFORMANCES WERE DOCUMENTED. INCIDENT WAS DETERMINED TO BE A DEFECT IN COMPONENT MANUFACTURED BY SUPPLIER MEDLINE. THE DEVICE HISTORY RECORD FROM SUPPLIER WAS REVIEWED, PRODUCT WAS FOUND TO MEET SPECIFICATIONS, NO NONCONFORMANCES WERE REPORTED. THERE WERE NO DESIGN CHANGES TO COMPONENT THAT WOULD HAVE CONTRIBUTED TO ISSUE. ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS WAS THE FIRST INCIDENT OF THIS NATURE REPORTED FOR THIS COMPONENT ISSUE. A QUALITY ALERT WAS INITIATED AND TEAMMATES WERE RETRAINED TO LOOK FOR THIS ISSUE. THE SUPPLIER MEDLINE HAS INDICATED THEY HAVE ONE SIMILAR COMPLAINT IN HISTORY; HOWEVER, NO TREND FOR THIS ISSUE.

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. AMERICAN CONTRACT SYSTEMS, INC. IS A CONVENIENCE KIT MANUFACTURER. THE COMPLAINT COMPONENT IS MEDLINE INDUSTRIES (NAMIC DIVISION) - (B)(4) (FDA REGISTRATION NUMBER: 3015910259), PART NUMBER 65011247. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION. 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN ISSUE WITH THE SYRINGE INSIDE THE KIT. THE EDGE OF SYRINGE PENETRATED THE PHYSICIAN'S GLOVE AND SKIN. THIS INCIDENT CONTAMINATED THE STERILE FIELD DUE TO THE GLOVE BREACH. INCIDENT OCCURRED DURING A CARDIAC CATH PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2631563 CATH LAB PACK CATH LAB PACK OES AMERICAN CONTRACT SYSTEMS, INC. SACL75 70-053242 00191072178404

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown