BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHANNEL DRAIN

    MDR report key: 23028122 · Received September 11, 2025

    Report

    Report Number
    1018233-2025-07919
    Event Type
    Malfunction
    Date Received
    September 11, 2025
    Date of Event
    September 5, 2025
    Report Date
    October 24, 2025
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    GBX
    UDI-DI
    00801741049873
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    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. INSTRUCTIONS FOR USE WERE REVIEWED FOR THIS INVESTIGATION. THE LABELING IS FOUND TO BE ADEQUATE AS IT STATES, TO AVOID THE POSSIBILITY OF DRAIN DAMAGE OR BREAKAGE: AVOID SUTURING THROUGH DRAINS. DRAINS SHOULD LIE FLAT AND IN LINE WITH THE SKIN EXIT AREAS. PARTICULAR CARE SHOULD BE TAKEN TO AVOID ANY OBSTACLES TO THE DRAIN EXIT PATH. DRAINS SHOULD BE CHECKED FOR FREE MOTION DURING CLOSURE TO MINIMIZE THE POSSIBILITY OF BREAKAGE. DRAIN REMOVAL SHOULD BE DONE GENTLY BY HAND. DRAINS SHOULD NOT BE HANDLED WITH POINTED, TOOTHED OR SHARP INSTRUMENTS WHICH COULD CAUSE CUTS OR NICKS AND LEAD TO SUBSEQUENT STRUCTURAL FAILURE OF THE DRAIN. SURGICAL REMOVAL MAY BE NECESSARY IF DRAIN IS DIFFICULT TO REMOVE OR BREAKS. A DHR COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. 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 THE DOCTOR RAISED SERIOUS SAFETY CONCERNS REGARDING THE RECENTLY CONVERTED BD JP DRAINS 072227 ¿ 10FR CHANNEL. ACCORDING TO THEIR FEEDBACK, THE NEW WOUND DRAINAGE ARE MORE DIFFICULT TO BEND AND LACK THE SHARPNESS OF THE PREVIOUSLY USED CARDINAL DRAINS JP-2227 ¿ 10FR CHANNEL. THAT REDUCED SHARPNESS WAS CAUSED EXCESSIVE STRETCHING OF THE SKIN AND SURROUNDING TISSUE DURING PLACEMENT, WHICH POSES A RISK TO PATIENT SAFETY. IN A RECENT CERVICAL CASE, THE ISSUE NEARLY RESULTED IN PATIENT HARM, AS AN ADDITIONAL INCISION HAD TO BE MADE JUST TO INSERT THE DRAIN SIGNIFICANTLY INCREASING THE RISK OF POSTOPERATIVE COMPLICATIONS SUCH AS HEMATOMA. DUE TO THESE CONCERNS, DOCTOR REQUESTED AN IMMEDIATE RETURN TO STOCKING THE ORIGINAL CARDINAL DRAINS FOR THEIR CASES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DOCTOR RAISED SERIOUS SAFETY CONCERNS REGARDING THE RECENTLY CONVERTED BD JP DRAINS 072227 ¿ 10FR CHANNEL. ACCORDING TO THEIR FEEDBACK, THE NEW WOUND DRAINAGE ARE MORE DIFFICULT TO BEND AND LACK THE SHARPNESS OF THE PREVIOUSLY USED CARDINAL DRAINS JP-2227 ¿ 10FR CHANNEL. THAT REDUCED SHARPNESS WAS CAUSED EXCESSIVE STRETCHING OF THE SKIN AND SURROUNDING TISSUE DURING PLACEMENT, WHICH POSES A RISK TO PATIENT SAFETY. IN A RECENT CERVICAL CASE, THE ISSUE NEARLY RESULTED IN PATIENT HARM, AS AN ADDITIONAL INCISION HAD TO BE MADE JUST TO INSERT THE DRAIN SIGNIFICANTLY INCREASING THE RISK OF POSTOPERATIVE COMPLICATIONS SUCH AS HEMATOMA. DUE TO THESE CONCERNS, DOCTOR REQUESTED AN IMMEDIATE RETURN TO STOCKING THE ORIGINAL CARDINAL DRAINS FOR THEIR CASES. CUSTOMER EMAIL RESPONSE RECEIVED ON 24SEP2025. IT WAS REPORTED THAT UNFORTUNATELY, THERE WAS NO SAMPLE PHOTO OF THE ISSUE. THAT WAS GONE OFF OF REPORTS FROM THE SURGEON. UNFORTUNATELY, THE ROOM DID NOT KEPT THE PACKAGE OF THE JP DRAIN THEY WERE HAD THE ISSUE WITH. THEY HAD BEEN COMPLAINED OF THAT PRODUCT THE MOMENT THEY SWITCHED OVER TO IT. PATIENT INITIALS ARE (B)(6), MALE 63-YEAR-OLD, 6¿, 235 LBS. NO FURTHER PATIENT INFORMATION WAS DISCLOSED. THE IMMEDIATE INTERVENTION THAT HAD TO BE MADE WAS THE INCISION OF THE SKIN AS THE TROCAR WAS UNABLE TO PENETRATE THROUGH THE SKIN IN THE NECK. THAT HAD ALSO BEEN DONE FOR OTHER CASES IN WHICH THIS WAS USED ACCORDING TO THE SURGEON. THESE DEVICES WERE ALSO TAKEN OFF THE SHELF FOR THEM AND HAD RETURNED TO PREVIOUS DRAINS BEING USED PRIOR TO THE CONVERSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2706247 CHANNEL DRAIN WOUND DRAIN GBX C.R. BARD INC. (COVINGTON) -1018233 UNK 00801741049873

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Other