BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIKING?

    MDR report key: 4298756 · Received December 4, 2014

    Report

    Report Number
    2134265-2014-07706
    Event Type
    Malfunction
    Date Received
    December 4, 2014
    Date of Event
    November 8, 2014
    Report Date
    November 8, 2014
    Manufacturer
    BOSTON SCIENTIFIC - LOWELL, MA
    Product Code
    DRF
    PMA / PMN Number
    K971265
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MFR SITE NAME: C.R. BARD (B)(4). IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE STERILE PACKAGING WAS NOT COMPLETELY SEALED. A VIKING 6F,115CM,JOS,4E,5MM CATHETER WAS SELECTED. THE OUTER BOX APPEARED " A LITTLE SQUASHED" BUT INTERNALLY, NO OBVIOUS DAMAGE WAS NOTED. AN ATTEMPT WAS MADE TO OPEN THE CATHETER PACKAGING; HOWEVER, IT WAS NOTICED THAT THE CATHETER POUCH WAS OPEN ALREADY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785255 VIKING? CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BOSTON SCIENTIFIC - LOWELL, MA H3114000041

    Patients

    Seq Age Sex Outcome Treatment
    1