BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDIA® COUDE OLIVE TIP URETHRAL FOLEY CATHETER

    MDR report key: 14575424 · Received June 2, 2022

    Report

    Report Number
    1018233-2022-04328
    Event Type
    Malfunction
    Date Received
    June 2, 2022
    Date of Event
    May 10, 2022
    Report Date
    September 14, 2022
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KOD
    UDI-DI
    00801741039058
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, 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. 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 INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE AS NO SAMPLE WAS RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE "OPERATOR ERROR". THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A LABELING REVIEW WAS NOT PERFORMED BECAUSE LABELLING COULD NOT HAVE PREVENTED THE REPORTED FAILURE. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF 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 BARD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER HAD THE BARD RED RUBBER URETHRAL CATHETER (B)(4) AND THE BARDIA RED RUBBER URETHRAL CATHETER (B)(4) AND WANTED TO KNOW THE DIFFERENCES BETWEEN THE PRODUCTS. REPRESENTATIVE MENTIONED THAT BOTH WERE SUPPOSED TO BE THE SAME CATHETER, BUT IN DIFFERENT PACKAGING AND BOTH WERE SUPPOSED TO BE RED RUBBER COUDE TIP WITH A SINGLE DRAINAGE EYE. HOWEVER, CUSTOMER STATED THAT THE CATHETER HAD TWO DRAINAGE EYES IN 802516 AND STATED BOTH PRODUCTS WERE IN THEIR PACKAGE AND HAVE NOT BEEN USED. REPRESENTATIVE STATED THAT IT WAS POSSIBLE THAT THE 802516 PACKAGE DIDN'T CONTAIN THE CORRECT CATHETER. AS PER THE FOLLOW UP VIA PHONE ON (B)(6) 2022, IT WAS REPORTED THAT THE PATIENT DECIDED TO USE THE BARD RED RUBBER URETHRAL CATHETER (B)(4) INSTEAD OF THE BARDIA RED RUBBER URETHRAL CATHETER (B)(4) AND JUST WANTED CLARIFICATION ON THE URETHRAL CATHETERS THEY RECEIVED, AND THIS WAS NOT A COMPLAINT BEING MADE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER HAD THE BARD RED RUBBER URETHRAL CATHETER (PCN-(B)(6).) AND THE BARDIA RED RUBBER URETHRAL CATHETER (PCN-(B)(6).) AND WANTED TO KNOW THE DIFFERENCES BETWEEN THE PRODUCTS. REPRESENTATIVE MENTIONED THAT BOTH WERE SUPPOSED TO BE THE SAME CATHETER, BUT IN DIFFERENT PACKAGING AND BOTH WERE SUPPOSED TO BE RED RUBBER COUDE TIP WITH A SINGLE DRAINAGE EYE. HOWEVER, CUSTOMER STATED THAT THE CATHETER HAD TWO DRAINAGE EYES IN (B)(6). AND STATED BOTH PRODUCTS WERE IN THEIR PACKAGE AND HAVE NOT BEEN USED. REPRESENTATIVE STATED THAT IT WAS POSSIBLE THAT THE (B)(6). PACKAGE DIDN'T CONTAIN THE CORRECT CATHETER. AS PER THE FOLLOW UP VIA PHONE ON 23MAY2022, IT WAS REPORTED THAT THE PATIENT DECIDED TO USE THE BARD RED RUBBER URETHRAL CATHETER (PCN-(B)(6)) INSTEAD OF THE BARDIA RED RUBBER URETHRAL CATHETER (PCN-(B)(6). AND JUST WANTED CLARIFICATION ON THE URETHRAL CATHETERS THEY RECEIVED, AND THIS WAS NOT A COMPLAINT BEING MADE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER HAD THE BARD RED RUBBER URETHRAL CATHETER (PCN-010116) AND THE BARDIA RED RUBBER URETHRAL CATHETER (PCN-802516) AND WANTED TO KNOW THE DIFFERENCES BETWEEN THE PRODUCTS. REPRESENTATIVE MENTIONED THAT BOTH WERE SUPPOSED TO BE THE SAME CATHETER, BUT IN DIFFERENT PACKAGING AND BOTH WERE SUPPOSED TO BE RED RUBBER COUDE TIP WITH A SINGLE DRAINAGE EYE. HOWEVER, CUSTOMER STATED THAT THE CATHETER HAD TWO DRAINAGE EYES IN 802516 AND STATED BOTH PRODUCTS WERE IN THEIR PACKAGE AND HAVE NOT BEEN USED. REPRESENTATIVE STATED THAT IT WAS POSSIBLE THAT THE 802516 PACKAGE DIDN'T CONTAIN THE CORRECT CATHETER. AS PER THE FOLLOW UP VIA PHONE ON 23MAY2022, IT WAS REPORTED THAT THE PATIENT DECIDED TO USE THE BARD RED RUBBER URETHRAL CATHETER (PCN-010116) INSTEAD OF THE BARDIA RED RUBBER URETHRAL CATHETER (PCN-802516) AND JUST WANTED CLARIFICATION ON THE URETHRAL CATHETERS THEY RECEIVED, AND THIS WAS NOT A COMPLAINT BEING MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2197807 BARDIA® COUDE OLIVE TIP URETHRAL FOLEY CATHETER COUDE OLIVE TIP URETHRAL FOLEY CATHETER KOD C.R. BARD, INC. (COVINGTON) -1018233 010116 NGFZ2731 00801741039058

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other