BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERGARD KNITTED BIFURCATED

    MDR report key: 12923797 · Received December 3, 2021

    Report

    Report Number
    1640201-2021-00038
    Event Type
    Malfunction
    Date Received
    December 3, 2021
    Date of Event
    October 25, 2021
    Report Date
    January 3, 2022
    Manufacturer
    INTERVASCULAR SAS
    Product Code
    DSY
    UDI-DI
    00384401000471
    PMA / PMN Number
    K964625
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (10/3236): THE INVOLVED PRODUCT WAS RETURNED TO INTERVASCULAR AND WAS INSPECTED BY THE QUALITY ASSURANCE (QA) SUPERVISOR FOR AN EVALUATION OF THE DAMAGE EXTENT. HIS OBSERVATIONS ARE AS FOLLOWS: "THE OUTER BOX OF THE PRODUCT IS TORN JUST NEXT TO THE CLOSING TAB ON 3 CM ONLY ON ONE SIDE OF THE BOX. THE TAMPER-EVIDENT LABELS ARE NOT CUT, SO THE BOX HAS NOT BEEN OPENED. THERE IS A MATCH BETWEEN THE PRODUCT, THE LABELING OF THE BOX AND THE PATIENT SET. THIS MAY HAVE OCCURRED DURING SHIPMENT/TRANSPORT OF THE PRODUCT TO THE END CUSTOMER OR DURING PREPARATION OF THE PACKAGE AT GXO FOR SHIPMENT TO THE END CUSTOMER BECAUSE THE PRODUCT WAS NEVER STORED AT THE END CUSTOMER'S LOCATION (PROBLEM DETECTED UPON DELIVERY TO THEM)." IN CONCLUSION, THE PRODUCT DOES NOT COMPLY WITH THE SPECIFICATIONS DUE TO A DAMAGED PACKAGING. (4308): THE MOST PROBABLE ROOT CAUSE OF THIS EVENT IS AN IMPROPER HANDLING OF THE PACKAGE DURING TRANSPORT BY THE LOGISTIC SUBCONTRACTOR. AN INTERNAL NON-CONFORMITY REPORT HAS BEEN INITIATED IN ORDER TO TAKE APPROPRIATE ACTION.

    Additional Manufacturer Narrative · 0

    ON DATE OF EVENT, THE EVENT DATE WAS SET ON (B)(6) 2021 AS IS WAS THE DAY THE PRODUCT DAMAGED WAS RECEIVED BY THE CUSTOMER. THE DAMAGE TO THE PRODUCTS OCCURRED BETWEEN THE DAY OF SHIPMENT AND THE DAY OF RECEIPT, WHICH IS BETWEEN (B)(6) 2021. IT WAS REPORTED THAT THE PRODUCT IS AVAILABLE FOR INVESTIGATION, IT SHOULD BE RETURNED TO INTERVASCULAR FOR EXAMINATION. THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME STERILIZATION LOT NUMBER 20L19. THE INVESTIGATION IS STILL ONGOING. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    SEE MFG REPORT(S) 1640201-2021-00038. COMPLAINT #(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING THE REVIEW OF IMPORTED PRODUCTS, A BOX WAS FOUND WITH THE SECONDARY PACKAGING BROKEN. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1823602 INTERGARD KNITTED BIFURCATED PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER DSY INTERVASCULAR SAS IGK1407 20L19 00384401000471

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose