BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH TEMPO AQUA 5F

    MDR report key: 1844920 · Received September 27, 2010

    Report

    Report Number
    9616099-2010-00722
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    July 2, 2010
    Report Date
    September 2, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQO
    PMA / PMN Number
    K000579
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    "THE RADIOLOGY TECH ASSISTING THE PHYSICIAN NOTICED THAT THE OUTER PART OF THE CATHETER WAS PEELING AWAY SHE NOTICED AFTER INSERTING THE CATHETER INTO THE PATIENT'S BODY ON THE PORTION THAT WAS STILL OUTSIDE OF THE BODY, SO SHE REMOVED THE CATHETER." ADDITIONAL INFORMATION DID NOT CLARIFY THE ISSUE. A NON-STERILE 5FR TEMP AQUA DIAGNOSTIC CATHETER WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE DISTAL SECTION OF THE STRAIN WAS MISSING. THE MOST PROXIMAL STRAIN RELIEF SECTION THAT WAS STILL ATTACHED TO THE CATHETER APPEARED CRACKED AND THE EDGES APPEARED BROKEN OFF. THE CATHETER HUB PRESENTED A YELLOWISH COLORATION. NO DAMAGES WERE OBSERVED ON THE REST OF THE CATHETER. SEM ANALYSIS WAS PERFORMED IN ORDER TO DETERMINE THE POSSIBLE ROOT CAUSE FOR THE CRACKED STRAIN RELIEF WITH MISSING MATERIAL. THIS CONCLUDED THAT MULTIPLE CRACKS WERE FOUND IN STRAIN RELIEF; THESE CRACKS SUGGEST BRITTLENESS OF THE MATERIAL WHICH IS UNCHARACTERISTIC OF THE STRAIN RELIEF MATERIAL. NO VISUAL EVIDENCE OF ANY CHEMICAL ATTACK WAS NOTED. THE EXACT CAUSE OF THE FAILURE COULD NOT BE CONCLUSIVELY DETERMINED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. CRACKING OF THE STRAIN RELIEF WITH PIECES MISSING WAS CONFIRMED ON THE RETURNED UNIT. ALTHOUGH THE EXACT CAUSE OF THE CRACKED STRAIN RELIEF COULD NOT BE CONCLUSIVELY DETERMINED, THERE ARE NO INDICATIONS THAT THIS IS RELATED TO THE MANUFACTURING PROCESS. CONTROLS ARE IN PLACE TO PREVENT DAMAGED UNITS FROM LEAVING THE FACILITY. NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME, GIVEN THAT THERE IS NO INDICATION THAT THIS ISSUE COULD BE RELATED TO THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    THE RADIOLOGY TECHNICIAN NOTICED THAT THE OUTER PART OF THE 5F TEMPO AQUA CATHETER WAS PEELING AWAY. A THIN LAYER OF THE BLUE CATHETER WAS COMING OFF. THIS WAS NOTICED AFTER INSERTING THE CATHETER INTO THE PATIENT'S BODY, ON THE PORTION THAT WAS STILL OUTSIDE OF THE BODY, THEREFORE THE CATHETER WAS REMOVED. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATH TEMPO AQUA 5F DIAGNOSTIC ENDOVASCULAR CATHETERS (DQO) DQO CORDIS DE MEXICO 14088242

    Patients

    Seq Age Sex Outcome Treatment
    1