BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYSORB 1 UD 5 X 18 BTP-1 DT

    MDR report key: 5510079 · Received March 18, 2016

    Report

    Report Number
    1219930-2016-00233
    Event Type
    Injury
    Date Received
    March 18, 2016
    Date of Event
    February 16, 2016
    Report Date
    February 22, 2016
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GAM
    PMA / PMN Number
    K963253
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF TWO DEVICES OPENED BY THE ACCOUNT WITH THE APPROPRIATE FOIL POUCHES AND RETAINERS IN AN UNDAMAGED CONDITION. THIS EVALUATION WAS BASED ON A TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, A PMV REVIEW OF COMPLAINT TRENDS, AND AN EVALUATION OF THE RETURNED PRODUCT. VISUAL INSPECTION OF THE RETURNED PRODUCT NOTED ZERO SUTURES AND ZERO NEEDLES. THE FOILS WERE INSPECTED WITH LIGHT ASSISTED MICROSCOPY WITH NO ABNORMALITIES. THE VISUAL INSPECTION OF ONE RETAINER REVEALED WITNESS MARKS IN THE FOAM NEEDLE RETAINER INDICATING THAT FOUR NEEDLES WERE PARKED IN THE RETAINER AT THE TIME OF MANUFACTURE; THE INTENDED QUANTITY IS FIVE NEEDLES. VISUAL INSPECTION OF THE SECOND RETAINER VERIFIED THAT THE CORRECT NUMBER OF WITNESS MARKS WERE PRESENT IN THE FOAM RETAINER. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THIS DEVICE LOT NUMBER WAS RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. A PRODUCT ENHANCEMENT HAS BEEN IMPLEMENTED TO PREVENT THIS CONDITION FROM REOCCURRING. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY AMENDED AS APPROPRIATE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: DURING THE FASCIA SUTURE FOR CLOSURE OF THE SURGICAL INCISION, ONE NEEDLE WAS NOTICED MISSING IN THE PACKET. AN X-RAY WAS PERFORMED TO SEARCH FOR THE NEEDLE, WHICH EXTENDED THE PROCEDURE FOR MORE 30 MINUTES; HOWEVER, IT WAS NOT FOUND IN THE BODY. WHEN THE PACKET WAS DOUBLE CHECKED, THE SPONGE WHICH SEATED THE NEEDLES HAD ONLY FOUR HOLES. WHERE THERE WOULD NORMALLY BE FIVE HOLES. PATIENT INFORMATION IS NOT AVAILABLE FROM THE REPORTER. THE PATIENT DID NOT SUFFER ANY TISSUE OR BLOOD LOSS OR DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167114 POLYSORB 1 UD 5 X 18 BTP-1 DT SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM COVIDIEN, FORMERLY US SURGICAL A DIVISON CLT15MG B5F0294X

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O