BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2845975 · Received November 26, 2012

    Report

    Report Number
    2024168-2012-07426
    Event Type
    Malfunction
    Date Received
    November 26, 2012
    Date of Event
    October 15, 2012
    Report Date
    November 2, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. WHILE THE REPORTED PRODUCT MIX-UP WAS CONFIRMED, BOTH REPORTED LOT NUMBERS WERE CONFIRMED TO HAVE BEEN MANUFACTURED AT TWO DIFFERENT FACILITIES; THUS, THE LOTS WOULD NOT HAVE COME INTO CONTACT WITH ONE ANOTHER DURING PRODUCTION. FURTHER REVIEW OF THE SHIPMENT RECORDS VERIFIED THAT THE HOSPITAL RECEIVED BOTH DEVICES; THIS MAY SUGGEST THAT A POTENTIAL DEVICE MIX-UP OCCURRED AT THE HOSPITAL AND NOT A PRODUCT DEFICIENCY. BASED ON ANALYSIS OF THE RETURNED DEVICE AND RECORDS REVIEW, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES FOR THIS LOT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE UNPACKING A 2.25 X 20 TREK RX BALLOON DILATATION CATHETER (BDC), THE FOLLOWING LABELING DISCREPANCIES WERE NOTED BETWEEN THE POUCH LABEL AND THE OUTER CHIPBOARD BOX: THE INTERNAL POUCH LABEL INDICATED A 2.25 X 20 SIZED DEVICE WITH LOT# 2040661 AND AN EXPIRATION DATE OF MARCH 2014. THE OUTER CHIPBOARD BOX LABEL INDICATED A 2.5 X 20 SIZED DEVICE WITH LOT# 20629G1 AND AN EXPIRATION DATE OF MAY 2014. THE DEVICE ITSELF INDICATES 2.25 X 20 ON ITS HUB. THERE WAS NO INDICATION THAT THE OUTER CHIPBOARD BOX HAD BEEN PREVIOUSLY OPENED OR UNSEALED. THE DEVICE WAS NOT USED IN THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING AN UNSPECIFIED DEVICE. THIS ISSUE DID NOT CAUSE OR CONTRIBUTE TO ANY CLINICALLY SIGNIFICANT DELAY, NOR ANY ADVERSE PATIENT EFFECTS AS THE DEVICE WAS NOT USED IN THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 2040661

    Patients

    Seq Age Sex Outcome Treatment
    1