BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 3003861 · Received March 14, 2013

    Report

    Report Number
    2210968-2013-02448
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 19, 2013
    Manufacturer
    ETHICON, INC
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY EVALUATED. RECEIVED 15 USED NEEDLES AND 1 BROKEN USED NEEDLE. ALL OF THE NEEDLES SHOWED INSTRUMENT/NEEDLE HOLDER MARKS IN ONE THIRD OF THE NEEDLE, STARTING FROM THE ATTACHMENT END TO THE SUTURE, AND IN THE TIP AREA. OUR INSTRUCTIONS FOR USE RECOMMEND GRIPPING THE NEEDLE IN THE AREA OF 1/3 TO 1/2 FROM THE ATTACHMENT END TO THE TIP TO AVOID DAMAGES OR BREAKAGES CAUSED BY HANDLING. CONCLUSION: REPRESENTATIVE SAMPLES FROM THE SAME LOT NUMBER AS THE ACTUAL DEVICE WERE RETURNED FOR EVALUATION. THE DEVICES WERE TESTED FOR STRENGTH AND DUCTILITY AND THE DEVICES MET PERFORMANCE SPECIFICATIONS.

    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. ADDITIONAL INFORMATION: THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS: BATCH EL8DKSM0, MFG DATE: 10/26/2012, EXP DATE: 12/31/2017. BATCH EL8HPCM0, MFG DATE: 11/05/2012, EXP DATE: 12/31/2017. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBERS WAS CONDUCTED AND THE BATCHES MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION ON (B)(6) 2013 AND SUTURE WAS USED. WHILE SUTURING THE UTERUS, THE NEEDLE BROKE. A XRAY WAS DONE TO LOCATE THE NEEDLE. HOWEVER, THE SURGEON WAS UNABLE TO REMOVE THE NEEDLE. AFTER APPROXIMATELY FIVE HOURS THE SURGEON DECIDED TO LEAVE THE NEEDLE IN SITU. THE PATIENT HAS RECOVERED WITH NO KNOWN ADVERSE EFFECTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107388 COATED VICRYL (POLYGLACTIN 910) SUTURE SUTURE, ABORBABLE GAM ETHICON, INC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other