BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTASEAL DUAL APPLICATOR

    MDR report key: 11625638 · Received April 6, 2021

    Report

    Report Number
    2210968-2021-03092
    Event Type
    Malfunction
    Date Received
    April 6, 2021
    Date of Event
    March 8, 2021
    Report Date
    March 9, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    MZM
    UDI-DI
    10705031462533
    PMA / PMN Number
    BK180287
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 4/30/2021. INVESTIGATION SUMMARY : THE CARTON FOR THE VST10 KIT WAS RETURNED. THE SECTION OF THE CARTON THAT CONTAINS THE LOT INFORMATION WAS RIPPED OFF. THE DUAL APPLICATOR WAS RETURNED WITH SPRAY AND DRIP TIP ATTACHED TO THE ADAPTER. THERE IS VISIBLE DAMAGE TO THE GRAY LUER CONNECTORS INDICATING A TOOL WAS USED TO TRY TO REMOVE THE TIP. THE EVALUATOR WAS ABLE TO REMOVE THE SPRAY AND TRIP TIP WITH THEIR HANDS WITH MINIMAL RESISTANCE FROM THE ADAPTER. IT IS UNKNOWN WHETHER THE CUSTOMER OVERTIGHTENED THE LUER CONNECTORS WITH THEIR TOOL WHEN THEY TRIED TO REMOVE THE TIP. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE POSSIBLE FINISHED DEVICE LOTS, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS: BATCH 2470297: MFG DATE IS JUN 24 ~JUN 26, 2019, EXP DATE: JUN 24, 2022. BATCH 252631: MFG DATE: OCT 14~OCT 21, 2019, EXP DATE: OCT 14TH, 2022. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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

    PRODUCT COMPLAINT # (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. THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS: 2470297 AND 2526310.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BARIATRIC PROCEDURE ON (B)(6) 2021 AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. DURING THE PROCEDURE THE LUER LOCK WAS STUCK AND WOULD NOT UNLOCK AND THE PROCEDURE WAS COMPLETED WITH A LIKE DEVICE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514759 VISTASEAL DUAL APPLICATOR FIBRIN SEALANT PREPARATION DEVICE MZM ETHICON INC. VSTAS1 10705031462533

    Patients

    Seq Age Sex Outcome Treatment
    1