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

Model Number	0102L18
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Pain (1994); Patient Problem/Medical Problem (2688); No Code Available (3191)
Date of Event	12/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was not returned.
Event or Problem Description
It was reported that the coude catheter fell out of the patient on (b)(6) 2019 after being placed on (b)(6) 2019.The patient went back to the emergency room to have a new catheter placed.
Additional Manufacturer Narrative
The reported event was confirmed, however, the cause is unknown.Four photo samples of a red rubber lubricath catheter with 0102l18 printed on the cap was returned with its balloon burst.A potential root cause could be due to "high modulus latex".As a physical sample was returned it cannot be determined if the device failed specifications.Based on the photo sample and the reported event, there appears to be a relationship between the device and the reported event.Based on the event, it appears that device was used or 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: "warning: on catheter, do not use ointments or lubricants having petrolatum base.They will damage latex and may cause the balloon to burst.5cc balloon: use 10ml sterile water" with the statement "do not exceed recommended capacities." 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.
Event or Problem Description
It was reported that the coude catheter fell out of the patient on (b)(6) 2019 after being placed on (b)(6) 2019.The patient went back to the emergency room to have a new catheter placed.Per follow up with patient's wife on (b)(6) 2020, it was reported that the balloon burst the day after placement, causing it to fall out of the patient prematurely.The patient was seen in the emergency room (er) due to difficulty urinating and pain.The patient also experienced elevated blood pressure (193/92) when vitals were checked in the er during his visit.The er nurse replaced the catheter and advised the patient to keep the new catheter in place for 5 days.There was no reported medical intervention and the patient is currently having no side effects due to the reported event.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER TIEMANN MODEL COUDE
• Common Device Name: COUDE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9671923
• Report Number: 1018233-2020-00730
• Device Sequence Number: 19476617
• Product Code: EZC
• UDI-Device Identifier: 00801741018138
• UDI-Public: (01)00801741018138
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2020

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 Expiration Date: 05/01/2022
• Device Model Number: 0102L18
• Device Catalogue Number: 0102L18
• Device Lot Number: MCBS3490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1