BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH 5F INFINITI TL JR4.0 100C

    MDR report key: 3151509 · Received June 7, 2013

    Report

    Report Number
    9616099-2013-00353
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    May 18, 2013
    Report Date
    May 21, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQO
    PMA / PMN Number
    K970854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION RECEIVED INDICATED THAT THE LUER HUB OF A JL4 CATHETER WAS MISSING. IT WAS NOTICED AFTER OPENING THE PACKAGE. THE DEVICE WAS STORED CORRECTLY. THE MISSING COMPONENT WAS NOT NOTICED PRIOR TO OPENING THE PACKAGING. THE PRODUCT WAS NOT RE-STERILIZED. NO PATIENT INJURY INVOLVED AND THE DEVICE WAS RETURNED FOR EVALUATION. ONE NON STERILE CORDIS 5F DX CATHETER WAS RECEIVED COILED INSIDE OF A PLASTIC BAG FOR ANALYSIS. THE LUER HUB WAS FOUND TO BE CRACKED AND SEPARATED AT THE THREAD AREA; THE FRAGMENT WAS NOT RECEIVED. NO OTHER VISUAL ANOMALIES WERE OBSERVED ON THE RETURNED UNIT. THE HUB OF THE RECEIVED DX CATHETER WAS SENT FOR SEM ANALYSIS IN ORDER TO IDENTIFY THE CAUSE OF THIS DAMAGE. THE FOUND CONDITIONS SUGGEST THAT THE SURFACE OF THE FRACTURE OF THE HUB EXHIBIT AREAS THAT ARE BRITTLE IN APPEARANCE. ALSO AN ELONGATION WAS FOUND AND DAMAGES AT THE NON FRACTURED SURFACE WERE FOUND. IT COULD NOT BE POSSIBLE TO DETERMINE WHAT CAUSED THE DAMAGES BUT IT CAN BE ATTRIBUTABLE AS A CAUSE OF THE FRACTURE PROBABLY A PRESSURE APPLIED TO THE HUB COULD CAUSE THE FRACTURE. NO VISUAL EVIDENCE OF ANY CHEMICAL DEGRADATION OR CUTTING IN THE MATERIAL WAS NOTED. SEVERAL TESTS WERE CARRIED OUT ON TWO DIFFERENT HUB LOTS IN ORDER TO EVALUATE DIFFERENCES BETWEEN THE COMPLAINT AND CRACKED SAMPLE THAT COULD PREDICT THE POSSIBLE CAUSE OF FRACTURES OBSERVED. FIRSTLY THE CHEMICAL COMPOSITION OF THE CRACKED WAS ELUCIDATED BY FTIR, WHERE IT WAS REVEALED THAT HUB IS PRIMARILY COMPOSED OF POLYURETHANE (PU)-TYPE POLYMER; IN ADDITION THE CONTROL SAMPLE ALSO EXHIBITED A SIMILAR COMPOSITION, THIS FORMULATION AGREES WITH THAT STATED IN THE SPECIFICATION ASSOCIATED WITH PART NUMBER 2950050. TGA (THERMO GRAVIMETRICAL ANALYSIS) REVEALED THAT DEGRADATION OF BOTH SAMPLES OCCURS IN ONE STEP AROUND 360°C, THE ONSET DEGRADATION TEMPERATURE WAS RATHER SIMILAR IN CRACKED AND REFERENCE SAMPLES OBTAINING VALUES OF 292 AND 295°C RESPECTIVELY. MACROSCOPIC AND MICROSCOPIC EVALUATION OF THE CRACKED HUB REVEALED THAT FRACTURE OBSERVED WAS BRITTLE IN SEM IMAGES SHOWED A CONCHOIDAL SURFACE INDICATIVE OF BRITTLENESS, NO DUCTILE DIMPLES AS WELL AS SIGNIFICANT MATERIAL DEFECTS WERE OBSERVABLE; THEREFORE IT IS SUGGESTED THAT HUB WAS CRACKED IN A BRITTLE MANNER. IN ADDITION TYPICAL SURFACE (POLISHED) OF A BRITTLE FRACTURE WAS OBSERVED DURING THE MACROSCOPIC EVALUATION. 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. THE REPORTED CUSTOMER COMPLAINT OF LUER HUB SEPARATED WAS CONFIRMED THROUGH FAILURE ANALYSIS. THE EXACT CAUSE OF THE FAILURE COULD NOT CONCLUSIVELY BE DETERMINED; HOWEVER IT IS POSSIBLE THAT IT IS RELATED TO THE MANUFACTURING PROCESS. AN INTERNAL INVESTIGATION HAS BEEN CREATED TO INVESTIGATE THIS ISSUE.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AFTER OPENING THE PACKAGE OF A JL 4 CATHETER IT WAS REPORTED THAT PART OF THE LUER HUB WAS MISSING. THERE WAS NO DAMAGE NOTED TO THE OUTER PACKAGING. THE DEVICE WAS STORED CORRECTLY. THE MISSING COMPONENT WAS NOT NOTICED PRIOR TO OPENING THE PACKAGING. THE PRODUCT WAS NOT RE-STERILIZED. NO PATIENT INJURY INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252784 CATH 5F INFINITI TL JR4.0 100C DIAGNOSTIC CARDIOLOGY CATHETER (DQO) DQO CORDIS DE MEXICO NA 15721947

    Patients

    Seq Age Sex Outcome Treatment
    1