BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRLNE BLU 30IN 4-0 D/A SH-1

    MDR report key: 16625191 · Received March 27, 2023

    Report

    Report Number
    2210968-2023-02129
    Event Type
    Malfunction
    Date Received
    March 27, 2023
    Date of Event
    February 7, 2023
    Report Date
    April 18, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    UDI-DI
    10705031016644
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4) DATE SENT TO THE FDA: 4/18/2023 ADDITIONAL INFORMATION: D4, H4, H6 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: I TOOK NOTE FROM ECM THERE IS AN UPDATE TO THE PRODUCT INVESTIGATION FOR (B)(4) WHERE THE PHYSICAL PRODUCT ANALYSIS IS ADDED. HOWEVER, I WOULD LIKE TO HIGHLIGHT AS PER MY EMAIL BELOW, THE 8526H SAMPLE IS ACTUALLY NOT FOR THIS COMPLAINT (B)(4) - THE CORRECT PC# FOR THE SAMPLE IS (B)(4). AS SUCH, MAY I REQUEST YOUR END TO AMEND THE PI ACCORDINGLY? - (B)(4) ((B)(6)): AS PER NOTE A-8915596, THE SAMPLE IS NOT FOR THIS PC#. HENCE, KINDLY REMOVE THE PRODUCT RETURN ANALYSIS FROM THE PRODUCT INVESTIGATION. - (B)(4) ((B)(4)): AS PER NOTE A-8915541, THE SAMPLE IS FOR THIS PC#. HENCE, KINDLY ADD THE PRODUCT RETURN ANALYSIS (AS ABOVE) TO (B)(4). PLEASE LET ME KNOW IF YOU REQUIRE FURTHER CLARIFICATION ON THE ABOVE. MANY THANKS AND APOLOGIES FOR THE INCONVENIENCE CAUSED. 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. PRODUCT COMPLAINT # (B)(4) DATE SENT TO THE FDA: 4/18/2023 CORRECTED INFORMATION: G1 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 · 0

    PRODUCT COMPLAINT # (B)(4). 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. 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 VIA: 1. PLEASE PROVIDE THE LOT NUMBER. ANS: NOT AVAILABLE. 2. WAS THERE ANY ADVERSE CONSEQUENCE ASSOCIATED WITH THE PATIENT? ANS: NO ADVERSE CONSEQUENCES WAS NOTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A MITRAL VALVE REPLACEMENT PROCEDURE ON (B)(6) 2023 AND SUTURE WERE USED. DURING THE PROCEDURE, THE SUTURE DETACHED FROM NEEDLE INTRA-OP. NEEDLE WAS FOUND AND DISCARDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419672 PRLNE BLU 30IN 4-0 D/A SH-1 SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. 8526H SDBHXB 10705031016644

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown