BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLOSED WOUND SUCTION

    MDR report key: 23074620 · Received September 17, 2025

    Report

    Report Number
    1018233-2025-08241
    Event Type
    Malfunction
    Date Received
    September 17, 2025
    Date of Event
    September 15, 2025
    Report Date
    November 7, 2025
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    GCY
    UDI-DI
    00801741049569
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS AND NO SAMPLE WAS AVAILABLE FOR EVALUATION A LABELING REVIEW WAS NOT PERFORMED BECAUSE LABELING COULD NOT HAVE PREVENTED THE REPORTED FAILURE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. NO ADDITIONAL ACTIONS CAN BE TAKEN AT THIS TIME. CORRECTION: D. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTIONS 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 THE BD 10FR ROUND DRAINS - WE OPENED 3 DIFFERENT PACKAGES OF STERILE DRAINS AND ALL WERE UNUSABLE. THEY HAD FUZZY STICKY STUFF ON DRAINS AND THE THIRD ONE HAD FUZZY SUBSTANCE AND A HAIR INSIDE THE STERILE PACKAGING. REFERENCE NUMBER: (B)(4). ALL (3 PACKAGES) HAD SAME LOT NUMBER: NGKP0821. SURGEON HAS HAD SEVERAL ISSUES WITH 10F DRAINS FOR A WHILE ACROSS ALL OPERATING ROOMS LD, BL, BW. 1. WE ARE FINDING DEBRIS, POWDER- LIKE SUBSTANCE ON THEM. 2. VERY OFTEN THE DRAINS HAVE SMALL WHITE PIECES OF PLASTIC THAT ARE STUCK TO THE CLEAR PORTION OF THE DRAIN. IT IS SO FREQUENT THAT SURGEON HAS THE STAFF CHECK THE TUBING BEFORE WE INSERT THEM. ACCORDING TO SOME, THEY SEE THIS ACROSS DRAIN SIZES. NOT SURE IF SOMETHING IN THE MANUFACTURING CHANGED. 3. THERE HAVE BEEN TWO TIMES THAT THE DRAINS DID NOT FUNCTION AT THE END OF THE CASE. AFTER INVESTIGATING, THE SAME CLEAR JELL THAT IS AT THE END OF THE DRAIN BY THE TROCAR WAS FILLING THE FLUTED PART OF THE DRAIN AS WELL SO IT WAS NOT ABLE TO HOLD SUCTION. SURGEON IS HAVING STAFF FLUSH ALL THE DRAINS NOW BEFORE PLACEMENT AND CLOSE THE INCISION, SO WE KNOW THEY FUNCTION. EMI HAS FOUR DRAINS THAT SHE IS SENDING TO PRODUCT DEFECT TODAY [DATE REDACTED]. BD 10FR ROUND DRAINS REF. 072221, NGJW3604. PATIENT HERE FOR SURGERY. SURGEON ALWAYS USES TWO 10FR ROUND DRAINS. OPENED TWO DRAINS AT BEGINNING OF CASE, BOTH DRAINS HAD FUZZY MATERIAL ON THE DRAIN IN THE STERILE PACKAGING. THIS HAS HAPPENED BEFORE. SURGEON SWITCHED AND HAD TO USE 15FR DRAINS WHICH SHOWED NO CONTAMINATION. BD 10FR ROUND DRAINS. REF: 072221, NGKP0821. BL OR DRAIN ISSUES - SURGICAL DRAIN BULBS HAD DEBRIS IN THEM. THESE RANGED FROM HAIR TO BLACK SPECS AND OTHER UNIDENTIFIABLE OBJECTS. (LOT: NGHZ0309), (LOT: NGKQ2776), (LOT: NGJW3939), AND (NGKQ0974).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 10FR ROUND DRAINS. THEY OPENED 3 DIFFERENT PACKAGES OF STERILE DRAINS, AND ALL WERE UNUSABLE. THEY HAD FUZZY STICKY STUFF ON DRAINS, AND THE THIRD ONE HAD FUZZY SUBSTANCE AND HAIR INSIDE THE STERILE PACKAGING. REFERENCE NUMBER 072221. ALL 3 PACKAGES HAD SAME LOT NUMBER NGKP0821. SURGEON HAS HAD SEVERAL ISSUES WITH 10F DRAINS FOR A WHILE ACROSS ALL OPERATING ROOMS LD, BL, BW.1. THEY FOUND DEBRIS, POWDER-LIKE SUBSTANCES ON THEM AND VERY OFTEN THE DRAINS HAD SMALL WHITE PIECES OF PLASTIC THAT ARE STUCK TO THE CLEAR PORTION OF THE DRAIN (LOT- NGJW3604). IT WAS SO FREQUENT THAT SURGEON HAD THE STAFF CHECK THE TUBING BEFORE THEY INSERT THEM. ACCORDING TO SOME, THEY SAW THAT ACROSS DRAIN SIZES. NOT SURE IF SOMETHING IN MANUFACTURING CHANGED AND THERE HAD BEEN TWO TIMES THAT THE DRAINS DID NOT FUNCTION AT THE END OF THE CASE. AFTER INVESTIGATING, THE SAME CLEAR GEL THAT WAS AT THE END OF THE DRAIN BY THE TROCAR FILLED THE FLUTED PART OF THE DRAIN AS WELL SO THAT IT COULD NOT HOLD SUCTION. SURGEON HAD STAFF FLUSH ALL THE DRAINS BEFORE PLACEMENT AND CLOSED THE INCISION, SO THEY KNEW IT FUNCTION (LOT - NGJW3604). EMI HAD FOUR DRAINS THAT WERE SENT TO PRODUCT DEFECT TODAY DATE REDACTED. PATIENT HERE FOR SURGERY. SURGEON ALWAYS USES TWO 10FR ROUND DRAINS. OPENED TWO DRAINS AT BEGINNING OF CASE, BOTH DRAINS HAD FUZZY MATERIAL ON THE DRAIN IN THE STERILE PACKAGING. THIS HAS HAPPENED BEFORE. SURGEON SWITCHED AND HAD TO USE 15FR DRAINS WHICH SHOWED NO CONTAMINATION. BD 10FR ROUND DRAINS. REF (B)(4). (LOT-NGKP0821). BL OR DRAIN ISSUES - SURGICAL DRAIN BULBS HAD DEBRIS IN THEM. THESE RANGED FROM HAIR TO BLACK SPECS AND OTHER UNIDENTIFIABLE OBJECTS. LOT-NGHZ0309, LOT-NGKQ2776, LOT-NGJW3939, AND LOT-NGKQ0974.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1635476 CLOSED WOUND SUCTION WOUND DRAIN GCY C.R. BARD INC. (COVINGTON) -1018233 NGHZ0309 00801741049569

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other