BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SABER PTA DILATATION CATHETER

    MDR report key: 4250947 · Received November 14, 2014

    Report

    Report Number
    9616099-2014-00745
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 20, 2014
    Report Date
    January 9, 2015
    Manufacturer
    CORDIS CORPORATION
    Product Code
    LIT
    PMA / PMN Number
    K971010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THE CUSTOMER OPENED THE PACKAGE HE SAW A RIP IN THE STERILE PACKAGE (STERILITY WAS COMPROMISED). THE EXTERIOR PACKAGE (IN CARTON) WAS OK AND IT WAS DETERMINED THAT IT COULD NOT HAVE HAPPENED DURING TRANSPORT. THE OPEN SEAL WAS NOTED WHEN THEY OPENED THE BOX AFTER IT HAD BEEN RECEIVED, AND STORED IN THE LAB, PRIOR TO USE. THE DEVICE WAS STORED IN THE LAB IN A BOX WITH ALL OTHER BALLOONS. IT IS NOT KNOWN IF THE ACTUAL PRODUCT WAS DAMAGED BECAUSE THEY DID NOT USE IT. ONE NON-STERILE SABER 3MM10CM 90 CATHETER WAS RECEIVED COILED IN A PLASTIC BAG. NEITHER THE INNER PACKAGE NOR THE OUTER PACKAGE WERE RECEIVED WITH THE DEVICE. REVIEW OF LOT 17029238 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE REPORTED ¿PACKAGING/POUCH/BOX COMPROMISED STERILITY-STERILE BARRIER BREACHED¿ REPORTED BY THE CUSTOMER WAS NOT CONFIRMED SINCE NEITHER THE INNER PACKAGE NOR THE OUTER PACKAGE WERE RECEIVED WITH THE DEVICE. THE EXACT CAUSE OF THE FAILURE COULD NOT BE DETERMINED. FACTORS CONTRIBUTING TO THE DIFFICULTY EXPERIENCED BY THE CUSTOMER COULD NOT BE DETERMINED. NEITHER THE DHR NOR THE PRODUCT ANALYSIS SUGGEST THAT THE REPORTED ISSUE COULD BE RELATED TO THE MANUFACTURING PROCESS; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE OPEN SEAL WAS NOTED WHEN THEY OPENED THE BOX AFTER IT HAD BEEN RECEIVED, AND STORED IN THE LAB, PRIOR TO USING. THE DEVICE WAS STORED IN THE LAB IN A BOX WITH ALL OTHER BALLOONS. IT IS NOT KNOWN IF THE ACTUAL PRODUCT WAS DAMAGED BECAUSE THEY DID NOT USE IT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    WHEN THE CUSTOMER OPENED THE PACKAGE HE SAW A RIP IN THE STERILE PACKAGE (STERILITY WAS COMPROMISED). THE EXTERIOR PACKAGE (IN CARTON) WAS OK AND IT WAS DETERMINED THAT IT COULD NOT HAVE HAPPENED DURING TRANSPORT. ONE NON-STERILE SABER 3MM10CM 90 CATHETER WAS RECEIVED COILED IN A PLASTIC BAG. NEITHER THE INNER PACKAGE NOR THE OUTER PACKAGE WERE RECEIVED WITH THE DEVICE. REVIEW OF LOT 17029238 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE REPORTED ¿PACKAGING/POUCH/BOX COMPROMISED STERILITY-STERILE BARRIER BREACHED¿ REPORTED BY THE CUSTOMER WAS NOT CONFIRMED SINCE NEITHER THE INNER PACKAGE NOR THE OUTER PACKAGE WERE RECEIVED WITH THE DEVICE. THE EXACT CAUSE OF THE FAILURE COULD NOT BE DETERMINED. FACTORS CONTRIBUTING TO THE DIFFICULTY EXPERIENCED BY THE CUSTOMER COULD NOT BE DETERMINED. NEITHER THE DHR NOR THE PRODUCT ANALYSIS SUGGEST THAT THE REPORTED ISSUE COULD BE RELATED TO THE MANUFACTURING PROCESS; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    (B)(6). THE EXPIRATION DATE IS NOT AVAILABLE AT THIS TIME. THIS DEVICE IS AVAILABLE FOR ANALYSIS BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    WHEN THE CUSTOMER OPENED THE PACKAGE HE SAW A RIP IN THE STERILELY PACKAGE (STERILITY WAS COMPROMISED). THE EXTERIOR PACKAGE (IN CARTON) WAS OK AND IT WAS DETERMINED THAT IT COULD NOT HAVE HAPPENED DURING TRANSPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736746 SABER PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS CORPORATION 48003010S 17029238

    Patients

    Seq Age Sex Outcome Treatment
    1