BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAKE DRAIN

    MDR report key: 2113253 · Received June 3, 2011

    Report

    Report Number
    2210968-2011-00717
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 13, 2011
    Manufacturer
    ETHICON
    Product Code
    KOG
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBER: BATCH J102698 MFG DATE: 06/01/2010, EXP DATE: 06/30/2015 IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBERS WAS CONDUCTED AND THE BATCHES MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBER: BATCH J102698.

    Additional Manufacturer Narrative · 1

    CONCLUSION: ONE PIECE OF 10FR DRAIN ATTACHED TO THE BULB RESERVOIR OF A DIFFERENT MANUFACTURER WAS RETURNED FOR EVALUATION. ON THE DRAIN, APPROXIMATELY ONE CENTIMETER ABOVE THE BLACK POINT, A SMALL DAMAGE (CUT) MADE WITH SOME SHARP OBJECT WAS OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A THYROIDECTOMY ON (B)(6) 2011 AND A DRAIN WAS PLACED. FOLLOWING THE SURGERY, A CRACK WAS FOUND AT THE BLACK POINT. THE DOCTOR REPAIRED IT WITH TEGADERM AND THE DRAIN CONTINUED TO FUNCTION. THREE DAYS LATER, THE DRAIN WAS REMOVED FROM THE PATIENT AS SCHEDULED. THERE WERE NO ADVERSE CONSEQUENCE TO THE PATIENT. THE SURGEON OPINED THAT THE DAMAGE TO THE DRAIN MAY HAVE OCCURED WHEN HE WAS SUTURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLAKE DRAIN WOUND DRAINAGE SYSTEM KOG ETHICON NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1