BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910)

    MDR report key: 3023527 · Received March 27, 2013

    Report

    Report Number
    2210968-2013-02977
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ETHICON, INC
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE ACTUAL NEEDLE SHOWS A FRACTURE AT THE BACK-THIRD OF THE NEEDLE. ACCORDING TO THE VISUAL INSPECTION UNDER A LIGHT-MICROSCOPE, SEVERAL MARKS OF INSTRUMENT WERE FOUND AT THIS AREA AND AT THE BREAKPOINT WHICH INDICATES THAT THE NEEDLE WAS HANDLED THERE. FURTHERMORE THE NEEDLE APPEARS TO BE BENT UP BEFORE BREAKAGE. THE APPEARANCE OF THE BREAKAGE INDICATES THAT THE MATERIAL WAS OVERSTRESSED DURING USE. CONCLUSION: REPRESENTATIVE SAMPLES WERE RETURNED FOR EVALUATION. THEY WERE VISUALLY AND FUNCTIONALLY EXAMINED FOR DIAMETER, TENSILE STRENGTH AND DUCTILITY AND THEY MET THE REQUIREMENTS. 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). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. THE NEEDLE FRAGMENT WAS RETRIEVED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126438 COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE, ABSORBABLE GAM ETHICON, INC NA EG8DDLQ0

    Patients

    Seq Age Sex Outcome Treatment
    1