BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PVC CATHETERS STRAIGHT

    MDR report key: 22771404 · Received August 11, 2025

    Report

    Report Number
    3011175548-2025-000009
    Event Type
    Malfunction
    Date Received
    August 11, 2025
    Date of Event
    July 11, 2025
    Report Date
    September 12, 2025
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    GBZ
    UDI-DI
    20650862130328
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL FIELDS: H3, H6. RELATED MDR¿S: 3011175548-2025-0000093, 3011175548-2025-0000094, 3011175548-2025-0000097 & 3011175548-2025-0000096. THE CUSTOMER REPORTED THAT THE END OF THE 32 FR STRAIGHT PVC CATHETERS WAS FOUND TO BE OVAL INSTEAD OF ROUND WHICH CAUSED A KINK AND BLOCKAGE IN ONE CATHETER WHAT WAS FOUND DURING USE. THE USER REPORTED THAT THEY OBSERVED FOUR (4) ADDITIONAL CATHETERS WITHIN THEIR INVENTORY WITH THE SAME OVAL SHAPE AT THE END OF THE CATHETER. THE ADDITIONAL FOUR (4) CATHETERS WERE NOT USED. THE USER PROVIDED A PICTURE WHICH DOES SHOW THE DESCRIBED ISSUE. IT APPEARS AS IF THE CATHETER WAS COMPRESSED IN SOME WAY AND DOES NOT APPEAR OTHERWISE DAMAGED. THE USER ORIGINALLY HAD PLANNED TO RETURN THE UNUSED CATHETERS BUT CHANGED THEIR MIND BECAUSE ANOTHER CLINICIAN HAD BEEN ABLE TO USE THE CATHETERS WITHOUT ISSUE. THE LOTS OF THESE CATHETERS WERE MANUFACTURED BETWEEN JANUARY 22, 2025 AND MAY 13, 2025. DUE TO THE WIDE MANUFACTURING TIMEFRAME OF THESE LOTS AND THE LACK OF ANY OTHER COMPLAINTS OF THIS ISSUE, AS WELL AS THE LACK OF ANY INVENTORY FROM IN OR AROUND THAT TIME-FRAME CONTEMPORANEOUS SAMPLES WILL NOT BE EVALUATED. INFORMATION ABOUT THE PRODUCT STORAGE WAS NOT RECEIVED. NO OTHER COMPLAINTS OF THIS ISSUE HAVE BEEN RECEIVED AND THERE HAVE BEEN NO NCRS FOR THIS ISSUE FROM INCOMING INSPECTION OR MANUFACTURING. THEREFORE, THE MOST LIKELY CAUSE OF THE PROBLEM LIES WITHIN THE USER'S FACILITY. THE MANNER IN WHICH THE CATHETERS ARE STORED MAY COMPRESS THEM, LEADING TO THE SHAPE DEFORMATION. A DHR REVIEW WAS COMPLETED AND DID NOT IDENTIFY ANY ANOMALIES IN MANUFACTURING. NO EVIDENCE HAS BEEN IDENTIFIED TO INDICATE THAT MANUFACTURING OR DESIGN CONTRIBUTED TO THIS COMPLAINT. A RECURRING LOT NUMBER QUERY WAS CONDUCTED FOR EACH REPORTED LOT NUMBER AND THERE HAVE BEEN NO OTHER COMPLAINTS ASSOCIATED WITH THE PRODUCTION LOT OF FINISHED GOODS EXCEPT FOR THE ONES STATED IN THE REPORTED COMPLAINTS. THE IFU PROVIDES ADEQUATE INSTRUCTIONS FOR THE SETUP AND USE OF THE DEVICE. COMPLAINT TRENDING FOUND THAT THE ACTUAL OCCURRENCE LEVEL DID NOT EXCEED THE ANTICIPATED OCCURRENCE LEVEL. TWO EXCURSIONS WERE IDENTIFIED, TRIGGERED BY THESE COMPLAINTS, FOR WHICH (B)(4) WAS INITIATED. A COMPLAINT HISTORY REVIEW WAS COMPLETED WHICH FOUND NO SIMILAR COMPLAINTS. THIS COMPLAINT IS CONFIRMED BY THE PROVIDED PICTURE. IT CANNOT BE CONFIRMED THAT THE DEVICE WAS NONCONFORMING WHEN IT LEFT THE MANUFACTURING FACILITY. THE EVIDENCE INDICATES THAT THE MOST LIKELY CAUSE OF THE COMPLAINT IS THE STORAGE CONDITIONS/TECHNIQUE AT THE USER FACILITY. THE ROOT CAUSE OF THESE COMPLAINTS IS IMPOSSIBLE TO DEFINE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THEY HAD IDENTIFIED AN ISSUE WITH A RECENT BATCH OF CHEST TUBES RECEIVED. THE ENDS OF THE CHEST TUBES WERE OVAL-SHAPED ON THE DISTAL END RATHER THAN THE STANDARD ROUND SHAPE. THE OVAL SHAPE WAS NOT CONSISTENT WITH THE REQUIRED SPECIFICATIONS NEEDED FOR THE PATIENTS AND THE FACILITY WAS CONCERNED ABOUT KINKING/BLOCKAGES THAT COULD OCCUR IN THE PATIENT AND AFFECT CLINICAL PERFORMANCE. NOTE: IT WAS REPORTED THIS CHEST TUBE WAS NOTICED FROM THE HOSPITAL'S INVENTORY, PRIOR TO USE AND THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2003209 PVC CATHETERS STRAIGHT CATHETER, CHOLANGIOGRAPHY GBZ ATRIUM MEDICAL CORPORATION 8032 ME242799 20650862130328

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown N/A.