BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VCL CT BRD UD 18IN 4-0 S/A P-3 PRM MP

    MDR report key: 9933581 · Received April 7, 2020

    Report

    Report Number
    2210968-2020-02714
    Event Type
    Injury
    Date Received
    April 7, 2020
    Date of Event
    January 30, 2020
    Report Date
    March 10, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031040526
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE POSSIBLE BATCH NUMBERS ARE REPORTED AS FOLLOWS: BATCH MCZ249; EXPIRATION DATE: 02/28/2023. DATE OF MFG.: 03/09/2018. BATCH MEK708; EXPIRATION DATE: 04/30/2023. DATE OF MFG.: 05/25/2018. BATCH PGK239; EXPIRATION DATE: 05/31/2024. DATE OF MFG.: 06/21/2019. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE THE POSSIBLE BATCH NUMBERS, AND NO NON-CONFORMANCES WERE IDENTIFIED. ATTEMPTS ARE BEING 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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE PATIENT DEMOGRAPHIC INFO: AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? ON WHAT TISSUE WAS THE SUTURE USED? WHAT WAS THE TISSUE CONDITION, I.E., NORMAL OR THIN, CALCIFIED, FRAGILE, DISEASED? WHAT INSTRUMENTS WERE USED TO GRASP THE NEEDLE? WHERE WAS THE NEEDLE GRASPED DURING USE? WERE XRAYS PERFORMED TO LOCALIZE THE NEEDLE FRAGMENT? IN WHAT TISSUE/STRUCTURE WAS THE NEEDLE PIECE RETAINED? DOES THE PIECE/DEVICE REMAIN RETAINED IN THE PATIENT¿S TISSUE OR WAS THE DEVICE/FRAGMENT REMOVED IN THE OPERATING ROOM? IF THE PIECE IS RETAINED, WHERE IS THE PIECE LOCATED, IN WHAT STRUCTURE? IF RETAINED, WERE THERE ANY PATIENT CONSEQUENCES? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS. WILL PRODUCT BE RETURNED, RETURN DATE, TRACKING INFORMATION. WHAT IS PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT. WHAT IS THE PATIENT¿S CURRENT STATUS?

    Description of Event or Problem · 1

    IT WAS REPORTED VIA USER FACILITY MW#5093123 THAT THE PATIENT UNDERWENT LACERATION CLOSURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE THE SUTURE NEEDLE BROKE OFF IN THE PATIENT AND HAD TO BE REMOVED IN THE OPERATING ROOM. IT WAS REPORTED TO BE UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND UNKNOWN IF THE PATIENT SUFFERED FURTHER CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396913 VCL CT BRD UD 18IN 4-0 S/A P-3 PRM MP SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. J494G 10705031040526

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention