BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHLN BLK 18IN 5-0 S/A SC-20

    MDR report key: 19961938 · Received August 12, 2024

    Report

    Report Number
    2210968-2024-08352
    Event Type
    Malfunction
    Date Received
    August 12, 2024
    Date of Event
    January 1, 2024
    Report Date
    October 7, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    UDI-DI
    17891338320294
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 8/12/2024. H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. 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. D4: UDI: THE MANUFACTURING AND EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: 1. PLEASE CLARIFY THE PRODUCT CODE AND LOT NUMBER OF THE PRODUCT. 2. STATUS OF PRODUCT RETURN. TODAY I CONTACTED MS. (B)(6) (PHARMACIST (B)(6)) / TEL: (B)(6) EMPLOYEE WHO IS REPLACING THE OWNER WHO COMPLAINED ABOUT THE QUALITY OF THE MATERIAL. MS. (B)(6) SAID THAT THE PRODUCT WAS DAMAGED DURING THE SURGICAL PROCEDURE BUT THAT SHE HAD NO FURTHER INFORMATION UNTIL THE OWNER RETURNED FROM VACATION ON FRIDAY (B)(6). THE REPORT SHOWS THAT THE BATCH IS NOT AC4123, BUT AV4123 WITH THE FOLLOWING INFORMATION: SALES ORDER CREATE DATE: (B)(6) 2024. SOLD TO (BILLING CODE): (B)(4). SHIP TO: (B)(4). CUSTOMER NAME: (B)(6). CITY: (B)(6). JOHNSON ORDER NUMBER: (B)(4). CUSTOMER ORDER: (B)(4). MATERIAL CODE: 14501T. DELIVERY: (B)(4). NF: (B)(4). ORDER LINE: (B)(4). MATERIAL DESCRIPTION: ETHILON* BLK 5-0 45CM (1) SC-20. BILLING CD: (B)(4). LOT: AV4123. 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 Manufacturer Narrative · 0

    (B)(4). 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE WIRE CAME BROKEN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2274416 ETHLN BLK 18IN 5-0 S/A SC-20 SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC. AV4123 17891338320294

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown