BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUILL SRS

    MDR report key: 1812480 · Received August 13, 2010

    Report

    Report Number
    2522801-2010-00021
    Event Type
    Malfunction
    Date Received
    August 13, 2010
    Date of Event
    July 19, 2010
    Report Date
    August 13, 2010
    Manufacturer
    SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)
    Product Code
    GAW
    PMA / PMN Number
    K052373
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT WAS UNDER ANESTHESIA FOR AN ADDITIONAL TWENTY (20) MINUTES BEFORE THE NEEDLE WAS LOCATED. THE DATE OF THIS EVENT IS ESTIMATED. THE ACTUAL FAILED DEVICE WAS NOT RETURNED FOR EVAL. HOWEVER, STERILE PRODUCT FROM THE SAME FINISHED GOOD LOT WAS RETURNED FOR TESTING ON 08/10/2010. METHOD: THE ACTUAL FAILED DEVICE WAS NOT RETURNED FOR EVAL. HOWEVER, STERILE PRODUCT FROM THE SAME FINISHED GOOD LOT WAS RETURNED FOR TESTING ON 08/10/2010 AND FORWARDED TO (B)(4) QUALITY ASSURANCE LABORATORY. RESULTS/CONCLUSIONS: THE RETURNED STERILE SAMPLES WERE VISUALLY EXAMINED PRIOR TO UNDERGOING STRAIGHT PULL AND, NEEDLE PULL TESTS PERFORMED BY A QUALITY ASSURANCE TECHNICIAN. ALL SAMPLES MET ANGIOTECH AND USP REQUIREMENTS. FURTHERMORE, RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD WERE REVIEWED AND NO CORRESPONDING ISSUES WERE IDENTIFIED DURING MANUFACTURING OR FINAL RELEASE. TO DATE, NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR NEEDLES DETACHING FOR THIS SPECIFIC ITEM NUMBER OR FINISHED GOOD LOT. (B)(4), QUILL SRS, #2 PPN, LOT M105730.

    Description of Event or Problem · 1

    THE DATE OF THE EVENT IS ESTIMATED. DR. (B)(6) REPORTED THAT WHILE PERFORMING AN ABDOMINOPLASTY PROCEDURE USING QUILL SRS #2 POLYPROPYLENE SUTURE WITH A 36 MM TAPER POINT NEEDLE, THE NEEDLE DETACHED FROM THE SUTURE AND COULD NOT BE LOCATED FOR TWENTY (20) MINUTES. THE NEEDLE WAS RETRIEVED; HOWEVER, ADDITIONAL TIME UNDER ANESTHESIA WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUILL SRS BARBED SUTURE AND NEEDLE GAW SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH) JA-1007Q M105730

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention