BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910)

    MDR report key: 2141778 · Received June 27, 2011

    Report

    Report Number
    2210968-2011-00833
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 3, 2011
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. 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). RESULTS: THE RETURNED CONCERNED SAMPLE SHOWS A NEEDLE WITH A FRACTURE AT THE NEEDLE POINT. DURING VISUAL INSPECTION UNDER A LIGHT-MICROSCOPE OF THE BROKEN NEEDLE AND RETRIEVED NEEDLE POINT, SEVERAL HEAVY MARKS OF INSTRUMENT WERE FOUND IN THIS AREA AND DIRECTLY AT THE BREAKING POINT WHICH INDICATES THAT THE NEEDLE WAS HANDLED THERE. CONCLUSION: THE DEVICE INFORMATION FOR USE CAUTIONS THE USER THAT (B)(6) TO AVOID DAMAGING NEEDLE POINTS AND SWAGE AREAS, GRASP THE NEEDLE IN AN AREA ONE-THIRD (1/3) TO ONE-HALF (1/2) OF THE DISTANCE FROM THE SWAGED END TO THE POINT (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION PROCEDURE ON (B)(6) 2011 AND SUTURE WAS USED. DURING THE PROCEDURE , THE TIP OF THE NEEDLE BROKE OFF WHILE SUTURING THE TISSUE. THE SURGEON LOCATED THE NEEDLE TIP AND RETRIEVED IT WITH NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE, ABSORBABLE GAM ETHICON INC. NA CE8KKXP0

    Patients

    Seq Age Sex Outcome Treatment
    1