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

Model Number	800061
Medical Device Problem Code	Material Invagination (1336)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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 balloon of the catheter would not deflate.Reportedly, the sample port was cut which did not resolve the issue.A surgeon was called in to remove the catheter.The catheter was removed by pulling it out of the patient.The balloon still contained fluid and was mushroomed.The patient reportedly had an enlarged prostate before use of the catheter.There was no impact to the patient.
Event or Problem Description
It was reported that the balloon of the catheter would not deflate.Reportedly, the sample port was cut which did not resolve the issue.A surgeon was called in to remove the catheter.The catheter was removed by pulling it out of the patient.The balloon still contained fluid and was mushroomed.The patient reportedly had an enlarged prostate before use of the catheter.There was no impact to the patient.
Additional Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use was found adequate and states the following: "warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage latex and may cause balloon burst.".

• Brand Name: BARD® FOLEY TRAY WITH BARD® HYDROPHILIC-COATED FOLEY CATHETER
• Common Device Name: LUBRICATH FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7996933
• Report Number: 1018233-2018-04895
• Device Sequence Number: 13559953
• Product Code: EZC
• UDI-Device Identifier: 00801741024153
• UDI-Public: (01)00801741024153
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2018

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 Model Number: 800061
• Device Catalogue Number: 800061
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 11/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1