BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSER RECANALIZATION SYSTEM

    MDR report key: 24016868 · Received January 9, 2026

    Report

    Report Number
    2020394-2025-02356
    Event Type
    Malfunction
    Date Received
    January 9, 2026
    Date of Event
    December 15, 2025
    Report Date
    January 29, 2026
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    PDU
    UDI-DI
    00801741202421
    PMA / PMN Number
    K203363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H11: AS THE SERIAL NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. HOWEVER, PHOTOS WERE PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. 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

    H11: MANUFACTURING REVIEW: A DHR AND MANUFACTURING REVIEW WAS NOT REQUIRED AS THE EVENT WAS DETERMINED TO BE EXPECTED, AND THE INVESTIGATION DID NOT IDENTIFY ANY MANUFACTURING AND/OR SERVICE-RELATED ISSUES. INVESTIGATION SUMMARY: THE BD RECANALIZATION SYSTEM SERIAL NUMBER (B)(6) WAS RECEIVED AT THE BD-BARD GLOBAL SERVICE & REPAIR. THE BD RECANALIZATION SYSTEM WAS VISUALLY INSPECTED UPON RECEIPT AND WAS FOUND TO BE DAMAGED. THE PRODUCT LABEL WAS MISSING. ONE PHOTO OF THE GENERATOR WAS PROVIDED. IN THE PHOTO, THE REAR VIEW OF THE CONSOLE IS VISUALIZED. THE POLE CLAMP, POWER SWITCH AND POWER ENTRY WAS VISIBLE IN THE IMAGE. A SMALL ZIP LOCK COVER WAS PLACED ABOVE IT WITH A SCREW INSIDE, AND NO LABEL INFORMATION IS AVAILABLE IN THE PROVIDED IMAGE. NO OTHER ANOMALIES WERE IDENTIFIED. THEREFORE, THE INVESTIGATION IS DETERMINED TO BE CONFIRMED FOR THE IDENTIFIED PRODUCT LABEL IS MISSING ISSUE. THE ROOT CAUSE FOR IDENTIFIED PRODUCT LABEL IS MISSING ISSUE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. LABELING REVIEW: THE LABELING/PACKAGING REVIEW WAS NOT REQUIRED AS THE REPORTED EVENT IS NOT ASSOCIATED WITH A LABELING, PACKAGING, OR USE RELATED ISSUE. G3, H6 (METHOD, RESULT, CONCLUSION), H8. 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 THERE ARE NO ALLEGED ISSUES WITH THIS BDRECANSYSTEM. THIS DEVICE IS BEING RETURNED TO SERVICE CENTER TO GET THE LATEST SOFTWARE VERSION UPDATE. THERE IS NO PATIENT INVOLVEMENT. DURING EVALUATION, IT WAS IDENTIFIED THAT THE BDRECANSYSTEM'S PRODUCT LABEL WAS MISSING. THE 6-32 X 1/4 PAN HEAD SCREW IS ATTACHED TO THE DEVICE IN A ZIPLOC BAG, AND THE PEM NUT IS SCREWED ONTO THE PAN HEAD SCREW. THE CABLE TIE HOLDER THAT HOLDS THE PUMP CABLE FERRITE BEAD IS LOOSE FROM THE DOUBLE-SIDED TAPE. THE BACK PLATE DOES NOT HAVE PEM NUTS. THE POWER ENTRY PLATE PEM NUT IS DISLODGED AND THREADED ONTO THE PAN HEAD SCREW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE ARE NO ALLEGED ISSUES WITH THIS BDRECANSYSTEM. THIS DEVICE IS BEING RETURNED TO SERVICE CENTER TO GET THE LATEST SOFTWARE VERSION UPDATE. THERE IS NO PATIENT INVOLVEMENT. DURING EVALUATION, IT WAS IDENTIFIED THAT THE BDRECANSYSTEM'S PRODUCT LABEL WAS MISSING. THE 6-32 X 1/4 PAN HEAD SCREW IS ATTACHED TO THE DEVICE IN A ZIPLOC BAG, AND THE PEM NUT IS SCREWED ONTO THE PAN HEAD SCREW. THE CABLE TIE HOLDER THAT HOLDS THE PUMP CABLE FERRITE BEAD IS LOOSE FROM THE DOUBLE-SIDED TAPE. THE BACK PLATE DOES NOT HAVE PEM NUTS. THE POWER ENTRY PLATE PEM NUT IS DISLODGED AND THREADED ONTO THE PAN HEAD SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80351 CROSSER RECANALIZATION SYSTEM RECANALIZATION SYSTEM PDU BARD PERIPHERAL VASCULAR, INC. 00801741202421

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown