BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910)

    MDR report key: 2063479 · Received April 19, 2011

    Report

    Report Number
    2210968-2011-00444
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    Manufacturer
    ETHICON
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBER: (B)(4), MFG DATE: 11/01/2010, EXP DATE: 07/31/2015. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBER WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. A NEEDLE THAT BROKE AT THE POINT END WAS SUBMITTED FOR THIS EVALUATION. A VISUAL INSPECTION OF THE SCANNING ELECTRON MICROSCOPE (SEM) PHOTOS WAS PERFORMED AND REVEALED INDENTS AND SCUFF MARKS AROUND THE BREAK AREA PRODUCED DURING HANDLING BY A SURGICAL NEEDLE HOLDERS OR SOME OTHER GRIPPING DEVISE. THE NEEDLE FRACTURED DUE TO TENSILE OVERLOAD GENERATED DURING SEVERE MECHANICAL DEFORMATION, WITH SIGNS OF DUCTILE FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGICAL PROCEDURE ON (B)(6) 2011 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE AT THE TIP DURING KNOTTED SUTURING OF THE FASCIA. NO FRAGMENT REMAINED IN THE PATIENT'S BODY. THERE WERE 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 NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1