BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAKE DRAIN

    MDR report key: 2066642 · Received March 24, 2011

    Report

    Report Number
    2210968-2011-00319
    Event Type
    Malfunction
    Date Received
    March 24, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    GBX
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    *

    Narratives

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 03/23/2011. PT CODE: 2199 LABELED. DEVICE CODE: 2203 - LABELED. 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. ADD'L INFO: THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS: BATCH J101423, MFG DATE: 05/01/2010, EXP DATE: 05/31/2015. BATCH J101147, MFG DATE: 04/01/2010, EXP DATE: 04/30/2015. 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 · 0

    DATE SENT TO THE FDA: 06/14/2011. RESULT: ONE PIECE OF 1/8 ADAPTER WAS RETURNED FOR EVALUATION. BOTH ENDS INNER DIAMETER WAS MEASURED AND THE RESULTS WERE WITHIN TOLERANCE. IN ADDITION, A FLOW TEST WAS PERFORMED WHEN THE ADAPTER WHICH WAS ATTACHED TO THE FLUTED ROUND 10FR DRAIN AND THE FLOW RESULT RECEIVED MET SPECIFICATION. CONCLUSION: NO DEVICE FAILURE DETECTED AND THE PRODUCT IS WITHIN SPECIFICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A RESECTION PROCEDURE OF A HEAD AND NECK TUMOR ON (B)(6) 2011 AND A DRAIN WAS PLACED. ON (B)(6) 2011, THE DRAINAGE WAS POOR BECAUSE THE INNER CAVITY OF THE ADAPTOR BECAME NARROWED. A DIFFERENT PRODUCT WAS USED WITH NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417601 BLAKE DRAIN WOUND DRAINAGE SYSTEM GBX ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown