BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE

    MDR report key: 3813640 · Received May 15, 2014

    Report

    Report Number
    2210968-2014-06171
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 28, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. 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

    CONCLUSION: ACTUAL SAMPLE WAS RETURNED FOR EVALUATION. A MICROSCOPIC VISUAL INSPECTION WAS PERFORMED AND REVEALED SCUFF MARKS AND INDENTS AROUND THE BREAK AREA PRODUCED DURING HANDLING BY THE SURGICAL NEEDLE HOLDERS OR SOME OTHER GRIPPING DEVICE. THE NEEDLE FRACTURED DUE TO TENSILE OVERLOAD GENERATED DURING SEVERE MECHANICAL DEFORMATION WITH SIGNS OF DUCTILITY. THERE WERE NO SIGNS OF MANUFACTURING DEFECTS FOUND ON THE NEEDLE.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION AND HYSTERECTOMY ON (B)(6) 2014 AND SUTURE WAS USED. WHILE TRYING TO SEPARATE THE UTERUS FROM THE BLADDER IN ORDER TO PERFORM THE HYSTERECTOMY, A 2 CM INJURY TO THE BLADDER OCCURRED. THERE WAS SIGNIFICANT BLEEDING FROM THE WIDE VEINS AT THE POSTERIOR- INFERIOR OF THE BLADDER, NEAR THE CERVIX. AN UROLOGICAL SURGEON WAS BROUGHT IN TO REPAIR THE BLADDER. ON THE FIRST PASS INTO THE BLADDER THE NEEDLE BROKE IN THE BLADDER WALL. THE SURGEON DECIDED TO CONTINUE THE BLADDER REPAIR AND NOT ATTEMPT TO RETRIEVE THE NEEDLE FRAGMENT DUE TO THE EXCESSIVE BLEEDING. THE RETAINED NEEDLE WAS MONITORED FROM (B)(6) 2014 UNTIL (B)(6) 2014 AND HAD NOT MIGRATED. THE PATIENT HAS BEEN DISCHARGED TO HOME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A CAESAREAN SECTION PROCEDURE ON (B)(6) 2014 AND SUTURE WAS USED TO SEW A BLADDER DUE TO BLEEDING. ON THE FIRST PASS OF THE NEEDLE IN THE BLADDER, THE NEEDLE BROKE, LEAVING A LARGER PART OF THE BROKEN NEEDLE INSIDE THE TISSUE. DUE TO SIGNIFICANT BLADDER BLEEDING, THE SURGEON OPINED NOT TO LOOK FOR THE NEEDLE AT THAT POINT AND CLOSED A BLADDER TO STOP BLEEDING. THEN THE BROKEN NEEDLE WAS DETECTED BY FLUOROSCOPY, BUT IT WAS NOT REMOVED. ADDITIONAL INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290298 VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK EP8DHZQ0

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other