BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN LATEX FOLEY CATHETER

    MDR report key: 22715472 · Received August 5, 2025

    Report

    Report Number
    1018233-2025-06487
    Event Type
    Malfunction
    Date Received
    August 5, 2025
    Date of Event
    July 11, 2025
    Report Date
    August 29, 2025
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    EZC
    PMA / PMN Number
    K910846
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 REPORTED EVENT WAS INCONCLUSIVE BECAUSE POOR SAMPLE CONDITION. THE PRODUCT WAS USED FOR UROLOGICAL CARE. BASED ON ATTACHED PHOTO, IT WAS OBSERVED THAT THERE WAS FOREIGN MATERIAL (PAPER FRAGMENTS) INSIDE THE CATHETER PACKAGE. THIS COMPLAINT IS CONSIDERED AS POOR SAMPLE DUE TO ONLY RECEIVED PHOTO IN TRACKWISE. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE DUE TO UNCLEAN WORKING AREA. THE DHR REVIEW COULD NOT BE PERFORMED WITHOUT A LOT NUMBER. UNABLE TO REVIEW THE LABELLING DUE TO UNKNOWN PRODUCT CODE. ALTHOUGH THE PRODUCT FAMILY IS UNKNOWN, THE FOLEY CATHETER IFUS ARE FOUND TO BE ADEQUATE BASED ON PAST REVIEWS. CORRECTION: D. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THE PATIENT WAS ADMITTED TO THE DEPARTMENT ON (B)(6) 2025 FOR HYPOSPADIAS. ON (B)(6) 2025, THE PATIENT UNDERWENT HYPOSPADIAS REPAIR SURGERY COMBINED WITH CIRCUMCISION UNDER SPINAL ANESTHESIA. DURING THE PROCEDURE, A SINGLE-USE STERILE URINARY FOLEY CATHETER WAS REQUIRED TO BE PLACED IN THE PATIENT. SURGEON DISCOVERED THAT THE STERILE URINARY CATHETER CONTAINED NUMEROUS UNKNOWN PAPER FRAGMENTS. SUSPECTING THAT THE CATHETER MIGHT ALSO CONTAIN FRAGMENTS, THE SURGEON DEEMED IT UNSAFE FOR USE DURING THE PROCEDURE. THEN IMMEDIATELY NOTIFIED THE OPERATING ROOM NURSE TO CONTACT THE UROLOGY DEPARTMENT TO REPORT THE SITUATION. THE NURSE PROMPTLY RETRIEVED A BRAND-NEW, UNDAMAGED STERILE URINARY FOLEY CATHETER FROM THE SUPPLY CENTER AND DELIVERED IT TO THE OPERATING ROOM TO COMPLETE THE PROCEDURE FOR THE PATIENT. THE PATIENT'S CONDITION WAS MONITORED POSTOPERATIVELY. THE SURGEON PROMPTLY IDENTIFIED THE ISSUE WITH THE CATHETER, PREVENTING ANY HARM TO THE PATIENT. IF THE ISSUE HAD NOT BEEN DETECTED IN TIME, IT COULD HAVE LED TO OTHER COMPLICATIONS OR PHYSICAL HARM TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THE PATIENT WAS ADMITTED TO THE DEPARTMENT ON (B)(6) 2025 FOR HYPOSPADIAS. ON (B)(6) 2025, THE PATIENT UNDERWENT HYPOSPADIAS REPAIR SURGERY COMBINED WITH CIRCUMCISION UNDER SPINAL ANESTHESIA. DURING THE PROCEDURE, A SINGLE-USE STERILE URINARY FOLEY CATHETER WAS REQUIRED TO BE PLACED IN THE PATIENT. SURGEON DISCOVERED THAT THE STERILE URINARY CATHETER CONTAINED NUMEROUS UNKNOWN PAPER FRAGMENTS. SUSPECTING THAT THE CATHETER MIGHT ALSO CONTAIN FRAGMENTS, THE SURGEON DEEMED IT UNSAFE FOR USE DURING THE PROCEDURE. THEN IMMEDIATELY NOTIFIED THE OPERATING ROOM NURSE TO CONTACT THE UROLOGY DEPARTMENT TO REPORT THE SITUATION. THE NURSE PROMPTLY RETRIEVED A BRAND-NEW, UNDAMAGED STERILE URINARY FOLEY CATHETER FROM THE SUPPLY CENTER AND DELIVERED IT TO THE OPERATING ROOM TO COMPLETE THE PROCEDURE FOR THE PATIENT. THE PATIENT'S CONDITION WAS MONITORED POSTOPERATIVELY. THE SURGEON PROMPTLY IDENTIFIED THE ISSUE WITH THE CATHETER, PREVENTING ANY HARM TO THE PATIENT. IF THE ISSUE HAD NOT BEEN DETECTED IN TIME, IT COULD HAVE LED TO OTHER COMPLICATIONS OR PHYSICAL HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2652203 UNKNOWN LATEX FOLEY CATHETER UNKNOWN LATEX FOLEY CATHETER EZC C.R. BARD INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other