BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIAVAC CLOSED WOUND SUCTION SYSTEM WITH HUBLESS SILICONE FLAT DRAIN, X-RAY OPA

    MDR report key: 17117105 · Received June 13, 2023

    Report

    Report Number
    1018233-2023-04272
    Event Type
    Malfunction
    Date Received
    June 13, 2023
    Date of Event
    May 19, 2023
    Report Date
    July 10, 2023
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    GBX
    UDI-DI
    00801741090745
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS UNCONFIRMED BECAUSE THE REPORTED FAILURE COULD NOT BE REPRODUCED. THE DEVICE MET RELEVANT SPECIFICATIONS. VISUAL EVALUATION OF THE RETURNED SAMPLE NOTED SIX UNOPENED (WITH ORIGINAL PACKAGING), HUBLESS SILICONE FLAT DRAIN. VISUAL INSPECTION OF THE SAMPLE NOTED THAT THE GTIN CODE 00801741090745 THAT IS USED IN LABEL PK7644433 IS FOR 1 (ONE) UNIT OF 0070370 AND FOUND TO BE ADEQUATE. A DHR REVIEW IS NOT REQUIRED AS THE EVENT IS UNCONFIRMED. AS THE REPORTED EVENT IS UNCONFIRMED A LABELING REVIEW IS NOT REQUIRED. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. H3 OTHER TEXT : THE ACTUAL/SUSPECTED DEVICE WAS INSPECTED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BARCODE FOR SINGLE UNITS OF SILICONE DRAIN WAS THE BARCODE FOR A BOX OF (B)(4) UNITS. AS PER THE ADDITIONAL INFORMATION RECEIVED ON 30MAY2023, THE CUSTOMER STATED THAT THE DISTRIBUTOR WHEN READ THE BAR CODE OF THE PRODUCT WHICH WAS SINGLE UNIT, THE DATA OF A BOX OF (B)(4) UNITS WERE DISPLAYED. IN OTHER WORDS, THE COMPLAINT WAS THAT THE BAR CODE ON THE PRODUCT WAS WRONGLY ATTACHED.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT THE BARCODE FOR SINGLE UNITS OF SILICONE DRAIN WAS THE BARCODE FOR A BOX OF 10 UNITS. AS PER THE ADDITIONAL INFORMATION RECEIVED ON 30 MAY 2023, THE CUSTOMER STATED, THAT THE DISTRIBUTOR WHEN READ THE BAR CODE OF THE PRODUCT WHICH WAS SINGLE UNIT. THE DATA OF A BOX OF 10 UNITS WERE DISPLAYED. IN OTHER WORDS, THE COMPLAINT, WAS THAT THE BAR CODE ON THE PRODUCT WAS WRONGLY ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206778 RELIAVAC CLOSED WOUND SUCTION SYSTEM WITH HUBLESS SILICONE FLAT DRAIN, X-RAY OPA SILICONE FLAT DRAIN GBX C.R. BARD, INC. (COVINGTON) -1018233 0070370 NGGW1247 00801741090745

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other