BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDIA® COUDE OLIVE TIP URETHRAL FOLEY CATHETER

    MDR report key: 15649865 · Received October 21, 2022

    Report

    Report Number
    1018233-2022-08048
    Event Type
    Malfunction
    Date Received
    October 21, 2022
    Date of Event
    October 12, 2022
    Report Date
    March 1, 2023
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KOD
    UDI-DI
    00801741039072
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT IS CONFIRMED, CAUSE UNKNOWN. THREE COUDE OLIVE TIP CATHETERS WERE RETURNED UNOPENED. THE CATHETERS WERE NOTED TO BE SMOOTH. CATHETER 1 - THE COUDE TIP DID NOT APPEAR TO BE ALIGNED WITH COUDE INDICATOR NOTCH WHEN THE CATHETER WAS REMOVED FROM THE PACKAGING AND LAID FLAT, THE CATHETER WAS THEN SECURED WITH TAPE TO REMAIN FLAT AND THE TIP AND COUDE INDICATOR NOTCH WERE NOTED BE BE ALIGNED. CATHETER 2 - THE COUDE TIP WAS NOTED TO ALIGN WITH THE COUDE INDICATOR NOTCH WHEN THE CATHETER WAS REMOVED FROM THE PACKAGING AND LAID FLAT. CATHETER 3 - THE COUDE TIP WAS NOTED TO ALIGN WITH THE COUDE INDICATOR NOTCH WHEN THE CATHETER WAS REMOVED FROM THE PACKAGING AND LAID FLAT. USING A FRENCH GAUGE ALL THREE CATHETERS WERE CONFIRMED TO BE 22FR., WHICH IS OUT OF SPECIFICATIONS WHICH STATES, "ACCEPT IF FRENCH SIZE MEASURES WITHIN +/- 1 FRENCH SIZE." ALTHOUGH A SPECIFIC CAUSE CANNOT BE DETERMINED, BASED ON THE RISK DOCUMENT A POTENTIAL ROOT CAUSE FOR THIS EVENT COULD BE, "INAPPROPRIATE PACKAGE DESIGN". THE DEVICE WAS NOT USED FOR PATIENT TREATMENT. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE." H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD. H3 OTHER TEXT: THE ACTUAL/SUSPECTED DEVICE WAS INSPECTED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD BEEN USING THE INTERMITTENT CATHETERS SINCE 1980 AND NOTICED AN ISSUE ON AND OFF FOR YEARS. CUSTOMER STATED THAT THE ISSUE WAS IT SEEMED ALL THE RED RUBBER INTERMITTENT CATHETERS WERE NOT THE SAME SIZE ALTHOUGH IT STATED IT WAS ON THE PACKAGE AND HOW THEY KNEW WAS THAT THE TIPS WERE OBVIOUSLY DIFFERENT IN SIZE AND IT AFFECTED THE RESULTS DURING USAGE. STATED THAT IF THE TIP WAS SMALLER THE CUSTOMER WAS SUCCESSFUL AND IF IT WAS LARGER OR FULLER THE CUSTOMER WAS NOT. PER CUSTOMER VIA EMAIL ON 24AUG2022, IT WAS STATED THAT IN A PACKAGE OF 15 INTERMITTENT CATHETERS, THE MAJORITY OF THE CATHETERS WERE TOO BIG. THE CUSTOMER PROVIDED TWO LOT NUMBERS (BATCH# NGGN0626 MATERIAL# 802520 ; BATCH# NGEP1662 MATERIAL# 802520). THE CUSTOMER STATED THAT THIS HAD BEEN GOING ON FOR A FEW YEARS. PER INVESTIGATOR NOTIFICATION ON 12OCT2022, IT WAS REPORTED THAT AN UNOPENED INTERMITTENT CATHETER SENT FOR SAMPLE EVALUATION WAS NOTED TO BE TWISTED WHEN RETURNED PER NOTIFICATION FROM INVESTIGATOR BASED ON SAMPLE EVALUATION ON 09FEB2023, IT WAS FOUND THAT THE STICKY RESIDUE WAS PRESENT ON THE SURFACE OF THE INTERMITTENT CATHETER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD BEEN USING THE INTERMITTENT CATHETERS SINCE 1980 AND NOTICED AN ISSUE ON AND OFF FOR YEARS. CUSTOMER STATED THAT THE ISSUE WAS IT SEEMED ALL THE RED RUBBER INTERMITTENT CATHETERS WERE NOT THE SAME SIZE ALTHOUGH IT STATED IT WAS ON THE PACKAGE AND HOW THEY KNEW WAS THAT THE TIPS WERE OBVIOUSLY DIFFERENT IN SIZE AND IT AFFECTED THE RESULTS DURING USAGE. STATED THAT IF THE TIP WAS SMALLER THE CUSTOMER WAS SUCCESSFUL AND IF IT WAS LARGER OR FULLER THE CUSTOMER WAS NOT. PER CUSTOMER VIA EMAIL ON (B)(6) 2022, IT WAS STATED THAT IN A PACKAGE OF 15 INTERMITTENT CATHETERS, THE MAJORITY OF THE CATHETERS WERE TOO BIG. THE CUSTOMER PROVIDED TWO LOT NUMBERS (BATCH#: NGGN0626 MATERIAL#: 802520 ; BATCH#: NGEP1662 MATERIAL#: 802520). THE CUSTOMER STATED THAT THIS HAD BEEN GOING ON FOR A FEW YEARS. PER INVESTIGATOR NOTIFICATION ON (B)(6) 2022, IT WAS REPORTED THAT AN UNOPENED INTERMITTENT CATHETER SENT FOR SAMPLE EVALUATION WAS NOTED TO BE TWISTED WHEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2558925 BARDIA® COUDE OLIVE TIP URETHRAL FOLEY CATHETER FOLEY CATHETER KOD C.R. BARD, INC. (COVINGTON) -1018233 802520 NGGN0626 00801741039072

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other