BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2511887 · Received March 30, 2012

    Report

    Report Number
    2024168-2012-02106
    Event Type
    Malfunction
    Date Received
    March 30, 2012
    Date of Event
    March 7, 2012
    Report Date
    March 9, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED MISLABELING WAS CONFIRMED. ANALYSIS NOTED THE LABEL ON THE CHIPBOARD BOX WAS: TREK RX 3.0X20MM PART# 1012274-20 AND LOT # 1121561. THE LABEL ON THE TYVEK POUCH LABEL WAS: TREK RX 3.50X12MM PART# 1012276-12 AND LOT # 102046Y. THE LABELING ON THE HUB WAS: TREK 3.50X12 AND LOT # 1020461 WHICH WOULD BE CONSISTENT WITH THE APPROPRIATE DEVICE IN THE TYVEK POUCH FOR LOT # 3.50X12MM PART # 1012276-12 AND LOT # 102046Y. THE TYVEK POUCH WAS SEALED AND HAD NOT BEEN OPENED. THERE WAS A TEAR AT THE TOP OF THE CHIPBOARD BOX AT THE FLAP WHERE THE CHIPBOARD BOX IS OPENED WHICH WOULD BE CONSISTENT WITH OPENING OF THE CHIPBOARD BOX DURING UNPACKING. THE LOT HISTORY RECORD FOR THE RX TREK 1012274-20/ 1121561 NOTED THAT THE LOT WAS MANUFACTURED AND RE-WORKED TO LOT NUMBER 112156Q IN (B)(4) ON 23-JANUARY 2012, WHEREAS THE RX TREK 1012276-12/ 102046Y LOT WAS MANUFACTURED AND RE-WORKED IN (B)(4) ON 30-JANUARY-2012, ONE WEEK BEFORE BETWEEN PRODUCTION OF BOTH LOTS. THEREFORE, CONCLUDING THAT THE LOT WOULD NOT HAVE COME INTO CONTACT WITH ONE ANOTHER DURING PRODUCTION OR RELABELING. FURTHER REVIEW OF THE SHIPMENT RECORDS VERIFIED THAT THE HOSPITAL RECEIVED 2 UNITS FROM THE RX TREK LOT 3.5X12 1012276-12/ 1020461 ON (B)(4) 2012. THEREFORE, IN REVIEW OF THE SHIPMENT RECORDS, THIS MAY SUGGEST THAT A POTENTIAL MIX-UP OCCURRED AT THE HOSPITAL. ALTHOUGH A CONCLUSIVE CAUSE CANNOT BE DETERMINED THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEVICE BOX WAS LABELED AS A TREK RX 3.0 X 20 AND LOT NUMBER 1121561; HOWEVER, WHEN THE DEVICE WAS REMOVED FROM THE BOX, IT WAS NOT THE TREK RX 3.0 X 20. THE SEALED PACKAGE CONTAINED A TREK RX 3.5 X 12 WITH LOT NUMBER 102046Y. THE BOX DID NOT APPEAR TO HAVE BEEN PREVIOUSLY OPENED. THE DEVICE WAS NOT USED IN THE PATIENT. A NC TREK 3.0 X 20 WAS USED IN THE CASE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 1121561

    Patients

    Seq Age Sex Outcome Treatment
    1