BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK SUTURE

    MDR report key: 2063432 · Received April 19, 2011

    Report

    Report Number
    2210968-2011-00449
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 13, 2011
    Report Date
    March 21, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    GAP
    PMA / PMN Number
    N11397
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 04/19/2011. (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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4): REPRESENTATIVE SAMPLES FROM THE SAME LOT NUMBER AS THE ACTUAL DEVICE WERE RETURNED FOR EVALUATION. THE DEVICES WERE VISUALLY AND FUNCTIONALLY EVALUATED. THE DEVICES MET VISUAL AND PERFORMANCE SPECIFICATIONS.IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NEONATE PATIENT UNDERWENT INTUBATION ON (B)(6) 2011. DURING INTUBATION, THE NEEDLE SNAPPED AS IT WAS WITHDRAWN WHEN BEING USED TO SUTURE THE ENDOTRACHEAL TUBE INTO PLACE. THIS LEFT THE BROKEN END OF THE NEEDLE IN THE ENDOTRACHEAL TUBE AND EXPOSED TO THE AIRWAY. THE AIRWAY WAS CLAMPED BELOW THE BROKEN NEEDLE AS THIS WAS VISIBLE IN THE TUBE AND WITHDRAWN FROM THE PATIENT'S AIRWAY. THE INTUBATION PROCEDURE HAD TO BE REPEATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILK SUTURE SUTURE, NONABSORBABLE GAP ETHICON, INC. NA CJP710

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Required Intervention