BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL CT BRD UD 27IN 3-0 S/A X-1

    MDR report key: 12121775 · Received July 6, 2021

    Report

    Report Number
    2210968-2021-05993
    Event Type
    Malfunction
    Date Received
    July 6, 2021
    Report Date
    June 10, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031040052
    PMA / PMN Number
    K022269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 8/16/2021. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED ADDITIONAL INFORMATION: H6. THE FOLLOWING INFORMATION WAS OBTAINED: QTY TO BE RETURNED: 1 => 0 . (DEVICE NOT AVAILABLE FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ALTHOUGH THE NEEDLE TIP WAS SEARCHED, IT WAS NOT FOUND, SO CLEANING AND SUCTION WERE REPEATED. THE NURSE COMMENTED THAT THE NEEDLE TIP WAS PROBABLY ASPIRATED. THE POSTOPERATIVE COURSE WAS UNEVENTFUL. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: COULD YOU PLEASE CONFIRM IF IT IS POSSIBLE THAT NEEDLE HAD FALL INTO THE PATIENT'S BODY? WERE X-RAYS TAKEN TO LOCATE THE NEEDLE PIECE(S)? WAS THE NEEDLE PIECE(S) RETRIEVED DURING THE SAME PROCEDURE? DOES A PIECE OF THE NEEDLE REMAIN IN THE PATIENTS TISSUE? WHAT WAS USED TO COMPLETE THE PROCEDURE? COULD YOU PLEASE PROVIDE LOT NUMBER?.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A NAIL REMOVAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING WOUND CLOSURE, IT WAS NOTICED THAT THE NEEDLE TIP HAD BEEN MISSING WHEN PUTTING THE 2ND OR 3RD STITCH. ALTHOUGH THE NEEDLE TIP WAS SEARCHED, IT WAS NOT FOUND, SO CLEANING AND SUCTION WERE REPEATED. THE NURSE COMMENTED THAT THE NEEDLE TIP WAS PROBABLY ASPIRATED. THE POSTOPERATIVE COURSE WAS UNEVENTFUL. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018410 VCL CT BRD UD 27IN 3-0 S/A X-1 SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. J458H 10705031040052

    Patients

    Seq Age Sex Outcome Treatment
    1