BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVICE, INTRAVASCULAR CATHETER SECUREMENT

    MDR report key: 5111090 · Received September 29, 2015

    Report

    Report Number
    3006260740-2015-00441
    Event Type
    Malfunction
    Date Received
    September 29, 2015
    Report Date
    August 21, 2015
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    KMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) OF JUZDF075, JUZFF035 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THESE LOT NUMBERS.

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. A LOT HISTORY REVIEW (LHR) OF JUZDF075 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, TREND ANALYSIS, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE (IF AVAILABLE), APPLICABLE FMEA DOCUMENTS, LABELING, AND APPLICABLE MANUFACTURE RECORDS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF AN OPEN SEAL WAS CONFIRMED AND THE CAUSE APPEARS TO BE MANUFACTURING RELATED. THE PRODUCT RETURNED FOR EVALUATION WAS ONE STATLOCK STABILIZATION DEVICE FOR MAQUET INTRA-AORTIC BALLOON (IAB) CATHETER PACKAGE. THE PACKAGE WAS RETURNED WITH THE STATLOCK DEVICE WITHIN. GROSS EXAMINATION OF THE PACKAGE REVEALED THAT THE TOP SEAL AND SIDE SEALS WERE COMPLETE AND CONTAINED NO VOIDS OR GAPS IN THE ADHESIVE TRANSFER AND BONDING BETWEEN THE TYVEK LIDSTOCK AND CLEAR PLASTIC BACK COVER. HOWEVER, THE SEAL AT THE BOTTOM OF THE PACKAGE CONTAINED A VOID IN THE ADHESIVE TRANSFER AND BONDING BETWEEN THE TYVEK LIDSTOCK AND CLEAR PLASTIC BACK COVER. IT APPEARS THE MANUFACTURE SEAL OF THIS PACKAGE WAS NEVER COMPLETE. FURTHER EVALUATION WILL BE PERFORMED AT THE MANUFACTURING FACILITY FOR THIS DEVICE. (B)(4) HAS BEEN OPENED TO ADDRESS THIS COMPLAINT.

    Description of Event or Problem · 1

    ALLEGATIONS MADE TO MANUFACTURING SITE OF OPEN SEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642398 DEVICE, INTRAVASCULAR CATHETER SECUREMENT SL CV FOR MAQUET LAB KMK BARD ACCESS SYSTEMS JUZDF075, JUZFF035

    Patients

    Seq Age Sex Outcome Treatment
    1