BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDIA® COUDE OLIVE TIP URETHRAL FOLEY CATHETER

    MDR report key: 19632316 · Received June 28, 2024

    Report

    Report Number
    1018233-2024-03823
    Event Type
    Malfunction
    Date Received
    June 28, 2024
    Date of Event
    June 11, 2024
    Report Date
    October 7, 2024
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KOD
    UDI-DI
    00801741039041
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS AVAILABLE FOR EVALUATION AND FURTHER INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS. ROOT CAUSE COULD NOT BE IDENTIFIED. ALTHOUGH A ROOT CAUSE COULD NOT BE DEFINITIVELY IDENTIFIED, BASED ON THE RISK DOCUMENTATION REVIEW, A POTENTIAL ROOT CAUSE FOR THIS TYPE OF FAILURE COULD BE "OPERATOR ERROR". HOWEVER, THERE WAS INSUFFICIENT INFORMATION TO CONFIRM THIS POTENTIAL ROOT CAUSE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. A LABELING REVIEW WAS NOT PERFORMED BECAUSE LABELING COULD NOT HAVE PREVENTED THE REPORTED FAILURE. CORRECTION: D. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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 INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. 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 THEY GOT TWO RETURNS OF INTERMITTENT CATHETERS ONE FOR 802516 AND ANOTHER FOR 802514. THE PATIENT WITH MATERIAL# 802514 SAID THE ENDS WERE TOO BIG ON THEIR SHIPMENT WITH LOT# NGGT5344. THE PATIENT WITH MATERIAL# 802516 SAID THAT THE CATHETER CAME TO THEM WERE SUPER THICK AND THEY SENT BACK CATHETER WITH LOT# NGGU0960, COMPARED TO WHAT THEY CURRENTLY HAVE IN THE SLOT LOT# NGHY2643. THE COLOR WAS NOTICEABLY DIFFERENT SO IT WAS POSSIBLE IT COULD BE A DIFFERENT FORM OF RUBBER. THE DARKER RED THEY SENT BACK HAD AN EXPIRATION OF 28FEB2027 AND THEY NOTICED THE EYELET WAS SMALLER ON THE DARKER ONE. THE ONES THEY CURRENTLY HAD WERE A LIGHTER RED WITH EXPIRATION OF 30APR2028 SO WHATEVER THEY RECEIVED WAS AN OLDER MANUFACTURE DATE, SO IT WAS POSSIBLE BARD HAD CHANGED SOMETHING AND AGAIN IT DID APPEAR THE EYELET HOLE WAS BIGGER ON THE LIGHTER COLOR. PER CUSTOMER VIA EMAIL RESPONSE ON 24JUN2024, IT WAS REPORTED THAT THE PRODUCT WAS USED ON A PATIENT AND THE DEFECT WAS ALSO NOTICED BEFORE USE. NO PATIENT HARM WAS REPORTED. IT WAS UNKNOWN WHETHER THE CATHETER AND EYELET DIMENSIONS WERE UNDER SPECIFICATION. THE MATERIAL WAS TOO THICK, AND RIGID COMPARED TO OTHER LOTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THEY GOT TWO RETURNS OF INTERMITTENT CATHETERS ONE FOR 802516 AND ANOTHER FOR 802514. THE PATIENT WITH MATERIAL# 802514 SAID THE ENDS WERE TOO BIG ON THEIR SHIPMENT WITH LOT# NGGT5344. THE PATIENT WITH MATERIAL# 802516 SAID THAT THE CATHETER CAME TO THEM WERE SUPER THICK AND THEY SENT BACK CATHETER WITH LOT# NGGU0960, COMPARED TO WHAT THEY CURRENTLY HAVE IN THE SLOT LOT# NGHY2643. THE COLOR WAS NOTICEABLY DIFFERENT SO IT WAS POSSIBLE IT COULD BE A DIFFERENT FORM OF RUBBER. THE DARKER RED THEY SENT BACK HAD AN EXPIRATION OF 28FEB2027 AND THEY NOTICED THE EYELET WAS SMALLER ON THE DARKER ONE. THE ONES THEY CURRENTLY HAD WERE A LIGHTER RED WITH EXPIRATION OF 30APR2028 SO WHATEVER THEY RECEIVED WAS AN OLDER MANUFACTURE DATE, SO IT WAS POSSIBLE BARD HAD CHANGED SOMETHING AND AGAIN IT DID APPEAR THE EYELET HOLE WAS BIGGER ON THE LIGHTER COLOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828846 BARDIA® COUDE OLIVE TIP URETHRAL FOLEY CATHETER URETHRAL FOLEY CATHETER KOD C.R. BARD, INC. (COVINGTON) -1018233 NGGT5344 00801741039041

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other