BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PUREWICK CAPITAL AND ACCESSORIES

    MDR report key: 24248016 · Received February 3, 2026

    Report

    Report Number
    1018233-2026-00556
    Event Type
    Malfunction
    Date Received
    February 3, 2026
    Date of Event
    January 20, 2026
    Report Date
    February 9, 2026
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    NZU
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. 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 INITIAL REPORTER'S ZIP CODE: (B)(6). THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. SINCE IT WAS GIVEN AS Z CODE (UNKNOWN PUREWICK CAPITAL), THE FMEA OF BOTH DRYDOC 1.0 AND 2.0 IS CONSIDERED. A LABELLING REVIEW COULD NOT BE PERFORMED SINCE NO MATERIAL NUMBER WAS PROVIDED. A DHR COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. NO ADDITIONAL ACTIONS CAN BE TAKEN AT THIS TIME. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. 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 THAT THE CUSTOMER SAID THAT SHE HAS PURCHASED 2 PW MACHINES. SHE WANTS US TO HONOR THE WARRANTY FOR THE OTHER MACHINE SINCE SHE SAYS IT DOESN'T HAVE THE BEST SUCTION. IT IS UNCLEAR IF TROUBLESHOOTING WAS PERFORMED. IT IS UNKNOWN IF LOT/SERIAL NUMBER WAS REQUESTED. NO MEDICAL IMPACT OR MEDICAL INTERVENTION REPORTED. USED WITH MALE WICKS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER SAID THAT SHE HAS PURCHASED 2 PW MACHINES. SHE WANTS US TO HONOR THE WARRANTY FOR THE OTHER MACHINE SINCE SHE SAYS IT DOESN'T HAVE THE BEST SUCTION. IT IS UNCLEAR IF TROUBLESHOOTING WAS PERFORMED. IT IS UNKNOWN IF LOT/SERIAL NUMBER WAS REQUESTED. NO MEDICAL IMPACT OR MEDICAL INTERVENTION REPORTED. USED WITH MALE WICKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136032 UNKNOWN PUREWICK CAPITAL AND ACCESSORIES PUREWICK NZU C.R. BARD INC. (COVINGTON) -1018233 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other