BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHANNEL DRAIN

    MDR report key: 22816273 · Received August 15, 2025

    Report

    Report Number
    1018233-2025-06804
    Event Type
    Malfunction
    Date Received
    August 15, 2025
    Date of Event
    August 11, 2025
    Report Date
    October 28, 2025
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    GBX
    UDI-DI
    00801741049798
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT IS CONFIRMED MANUFACTURING RELATED. VISUAL EVALUATION NOTED RECEIVED 1 UNOPENED CHANNEL DRAIN. UPON OPENING PACKAGING, DUST PARTICLES WERE PRESENT ON THE CHANNEL DRAIN. THEREFORE, THE REPORTED EVENT IS CONFIRMED AND DOES NOT MEET SPECIFICATIONS PER (B)(4) WHICH STATES "PRODUCT MUST BE CLEAN AND FREE FROM OIL OR GREASE OR LOOSE FOREIGN MATTER IN EXCESS OF AN AGGREGATE TOTAL OF 0.6MM² PER TAPPI DIRT ESTIMATION CHART OR 1/16IN. IN LENGTH." LABELLING REVIEW IS NOT REQUIRED AS LABELLING WOULD NOT HAVE PREVENTED THE REPORTED EVENT. DHR REVIEW DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. CORRECTION -B, D, F, H. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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 AN ADDITIONAL COMPLAINTS HAVE BEEN REPORTED REGARDING THE SAME ITEM, AND IT HAS BEEN IDENTIFIED THAT THE ISSUE MAY AFFECT MULTIPLE ITEMS BEYOND THE ORIGINALLY REPORTED 072221. A MEETING IS REQUESTED TO DISCUSS THE ISSUE FURTHER. CONSIDERATION IS BEING GIVEN TO REMOVING THE AFFECTED PRODUCT AND RELATED ITEMS FROM INVENTORY UNTIL CONFIRMATION OF RESOLUTION IS OBTAINED. IMPACTED ITEMS INCLUDE: 072211. 072190. 072189. 072214. 072186. ADDITIONAL REPORTS DATED (B)(6) FROM THE CUSTOMER ARE INCLUDED BELOW. COMMUNICATION FROM (B)(6) WAS SUBMITTED AND DOCUMENTED UNDER PR (B)(4) AND (B)(4), WITH CUSTOMER OUTREACH PENDING. NEW REPORTS SHOULD BE REVIEWED TO CONFIRM ALIGNMENT WITH PREVIOUSLY OPENED RECORDS. ENSURE INCLUSION OF BD CUSTOMER QUALITY AND RELEVANT STAKEHOLDERS IN ALL CUSTOMER COMMUNICATIONS. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 14AUG2025, IT WAS REPORTED THAT THEY SHARED CLINICIANS RAISED MULTIPLE CONCERNS RELATED TO ITEM 072221 AND THEN INSPECTED SIMILAR ITEMS AT THEIR DISTRIBUTION CENTER AND FOUND FUZZY HAIR FOREIGN MATTER IN THOSE ITEMS AS WELL. THERE WAS NO HARM TO A PATIENT AS THESE WERE FOUND BEFORE USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ADDITIONAL COMPLAINTS HAVE BEEN REPORTED REGARDING THE SAME ITEM, AND IT HAS BEEN IDENTIFIED THAT THE ISSUE MAY AFFECT MULTIPLE ITEMS BEYOND THE ORIGINALLY REPORTED 072221. A MEETING IS REQUESTED TO DISCUSS THE ISSUE FURTHER. CONSIDERATION IS BEING GIVEN TO REMOVING THE AFFECTED PRODUCT AND RELATED ITEMS FROM INVENTORY UNTIL CONFIRMATION OF RESOLUTION IS OBTAINED. IMPACTED ITEMS INCLUDE: 072211, 072190, 072189, 072214, 072186. ADDITIONAL REPORTS DATED AUGUST 11 FROM THE CUSTOMER ARE INCLUDED BELOW. COMMUNICATION FROM AUGUST 7 WAS SUBMITTED AND DOCUMENTED WITH CUSTOMER OUTREACH PENDING. NEW REPORTS SHOULD BE REVIEWED TO CONFIRM ALIGNMENT WITH PREVIOUSLY OPENED RECORDS. ENSURE INCLUSION OF BD CUSTOMER QUALITY AND RELEVANT STAKEHOLDERS IN ALL CUSTOMER COMMUNICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1300535 CHANNEL DRAIN CHANNEL DRAIN GBX C.R. BARD INC. (COVINGTON) -1018233 NGKN1625 00801741049798

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other