BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL* UND 4-0 45CM (1)E-19

    MDR report key: 11309536 · Received February 10, 2021

    Report

    Report Number
    2210968-2021-01253
    Event Type
    Injury
    Date Received
    February 10, 2021
    Date of Event
    November 20, 2020
    Report Date
    January 19, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 03/04/2021. ADDITIONAL H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. ADDITIONAL INFORMATION: H6. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: DDH PATIENT UNDER GENERAL + LOCAL ANESTHESIA. USG-GUIDED VJID PUNCTURE + METAL GUIDE INSERT, CONFIRMED GUIDE POSITION BY USG. RIGHT INFRACLAVICULAR INCISION + DIHESIS AND CAVITY MAKING IN THE SUBCUTANEOUS. POSITIONED AND FIXED RESERVOIR IN THE CAVITY, TUNNED CATHETER UP TO THE GUIDE. INSERTING THE CATHETER TO THE CENTRAL POSITION BY THE COMBINED TECHNIQUE SELDINGER + PEEL OFF. FLOW AND REFLUX TEST. CONFIRMATION OF THE CENTRAL POSITION OF THE CATHETER BY RADIOSCOPY. HEPARINIZED SYSTEM. SYNTHESIS + BANDAGE. USED: 1 VIDEO COVER, 1 AMP XYLESTESIN, 100ML SALINE SOLUTION, 0.5ML HEPARINE, 1 COTTON 3-0, 1 VICRYL 4-0, 1 CHILD LIFEPORT CATHETER. 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. FOR PATIENT IDENTIFIER ¿AAS¿, 5 YEARS: THE PATIENT DEMOGRAPHIC INFO FOR PATIENT (¿AAS¿): GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. NAME 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? HOW WAS THE SUTURE PLACED, INTERRUPTED OR CONTINUOUS? HOW WAS THE SUTURE INITIALLY TIED? WHAT TISSUE DEHISCED? WHAT WAS THE APPEARANCE OF THE SUTURE DURING THE SECOND PROCEDURE? DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER SUTURE PLACEMENT? THE EVENT AND INFORMATION PROVIDED FOR PATIENT ¿AAS¿ INDICATED J196G, LOT AN3529 AND J196G, LOT AL7173. PLEASE PROVIDE PRODUCT CODE AND LOT FOR ¿POLYCOT 3-0¿. OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? IF APPLICABLE, WILL PRODUCT BE RETURNED, RETURN DATE, TRACKING INFORMATION WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT¿S CURRENT STATUS? NOTE: EVENTS REPORTED VIA MW # 2210968-2021-01252, 2210968-2021-01254, 2210968-2021-01255.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT IMPLANTATION OF THE FULLY IMPLANTABLE CATHETER ON (B)(6) 2020 AND SUTURE WAS USED. ON (B)(6) 2020, THE PATIENT EXPERIENCED DEHISCENCE AT THE SUTURE SITE, REQUIRING A NEW CTI IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203950 VICRYL* UND 4-0 45CM (1)E-19 SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. AL7173

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention