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

Model Number	365718
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2020
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.
Event or Problem Description
It was reported that the catheter was inspected and found to have a hole on the balloon which allegedly caused fluids to leak out and the catheter to fall out of the patient.
Additional Manufacturer Narrative
The reported issue was confirmed.The device was returned for evaluation.Visual inspection noted a sac irregular burst.No pieces of the sac were missing.Introduced water into the inflation lumen and did not experience any obstructions to impede flow.Microscopic examination found no conditions that could be associated with the reported event.However the exact cause on how and when problem occurred could not be determined.Potential root cause for this failure mode could be user related (example: contact with sharp object)/ / exposure to petrolatum based products mechanical failure/operator error.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: ¿do not use ointments or lubricants having a petrolatum base.They will damage latex and may burst balloon.".
Event or Problem Description
It was reported that the catheter was inspected and found to have a hole on the balloon which allegedly caused fluids to leak out and the catheter to fall out of the patient.

• Brand Name: BARD® LUBRICATH® FOLEY CATHETER
• Common Device Name: HYDROGEL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9763989
• Report Number: 1018233-2020-01395
• Device Sequence Number: 11501175
• Product Code: EZC
• UDI-Device Identifier: 00801741077753
• UDI-Public: (01)00801741077753
• 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,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2020

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: 11/28/2023
• Device Model Number: 365718
• Device Catalogue Number: 365718
• Device Lot Number: 9AW044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 05/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1