MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® FOLEY CATHETER TIEMANN MODEL COUDE; COUDE RED RUBBER FOLEY CATHETER

Catalog Number	0102L14
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the staff who initially did gem treatment was on break.The user unclamped the catheter tubing to allow it to drain.When the user went back in to install docetaxel, the user noticed the patient¿s bed was all wet.Patient stated that they thought they were sweating.When instilling docetaxel, fluid was noted to be draining out the catheter tubing close to the hub.A waterproof tape was applied to the same and held with hand to finish instilling docetaxel.The co-staff member assisted to deflate the balloon and the catheter was removed.The patient was cleaned up with soap and water as per the policy and protocol.Bedding was placed in a proper red biohazard bin and the bed was cleaned with bleach by fellow staff members.The patient experienced inconvenience.
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that the staff who initially did gem treatment was on break.The user unclamped the catheter tubing to allow it to drain.When the user went back in to install docetaxel, the user noticed the patient¿s bed was all wet.Patient stated that they thought they were sweating.When instilling docetaxel, fluid was noted to be draining out the catheter tubing close to the hub.A waterproof tape was applied to the same and held with hand to finish instilling docetaxel.The co-staff member assisted to deflate the balloon and the catheter was removed.The patient was cleaned up with soap and water as per the policy and protocol.Bedding was placed in a proper red biohazard bin and the bed was cleaned with bleach by fellow staff members.The patient experienced inconvenience.
Additional Manufacturer Narrative
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 ¿inspection results (measurement, testing data) not verified by iqa assignee error of inspector".However, there was insufficient information to confirm this potential root cause.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Visually inspect the product for any imperfections or surface deterioration prior to use.Warning: on catheter, do not use ointments or lubricants having petrolatum base.They will damage latex and may cause the balloon to burst." 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.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER TIEMANN MODEL COUDE
• Common Device Name: COUDE RED RUBBER FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 19574106
• Report Number: 1018233-2024-03621
• Device Sequence Number: 8525367
• Product Code: EZC
• UDI-Device Identifier: 00801741018114
• UDI-Public: (01)00801741018114
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0102L14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown