BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910)

    MDR report key: 3003828 · Received March 14, 2013

    Report

    Report Number
    2210968-2013-02436
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 18, 2013
    Manufacturer
    ETHICON, INC.
    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: REPRESENTATIVE SAMPLES FROM THE SAME LOT NUMBER AS THE ACTUAL DEVICE WERE RETURNED FOR EVALUATION. NEEDLES AND SUTURES OF THE UNOPENED PACKETS WERE EXAMINED UNDER 10-X MAGNIFICATION FOR ATTRIBUTES DEFECTS. NO NEEDLE OR SUTURE DEFECTS WERE NOTED.

    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 INFORMATION: THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS: BATCH DK2479, MFG DATE: NI, EXP DATE: NI. BATCH EL2588, MFG DATE: NI, EXP DATE: NI. BATCH EC2829, MFG DATE: NI, EXP DATE: NI. BATCH EM2641, MFG DATE: NI, EXP DATE: NI. BATCH EE2147, MFG DATE: NI, EXP DATE: NI. 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 HYSTERECTOMY ON (B)(6) 2013 AND SUTURE WAS USED. WHILE SUTURING THE FASCIA, 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
    107345 COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE, ABSORBABLE GAM ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1