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

Model Number	365722
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Codes	Pain (1994); 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.
Event or Problem Description
It was reported that the foley catheter became blocked with white wormlike obstructions a few days after placement.The patient stated that the obstructions started near the tip of the foley catheter.After the first week of the initial blockage, the catheter became blocked again within 24-36 hours.
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 were found adequate and state the following: "single patient use only.Do not reuse.Do not resterilize.For urological use only.Visually inspect the product for any imperfections or surface deterioration prior to use.".
Event or Problem Description
It was reported that the foley catheter became blocked with white wormlike obstructions a few days after placement.The patient stated that the obstructions started near the tip of the foley catheter.After the first week of the initial blockage, the catheter became blocked again within 24-36 hours.Additional information was received from the complainant on 16 jan 2019, that the patient experienced pain.No medical intervention was reported.

• Brand Name: BARD® LUBRICATH® FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8268047
• Report Number: 1018233-2019-00350
• Device Sequence Number: 13492451
• Product Code: EZC
• UDI-Device Identifier: 00801741077777
• UDI-Public: (01)00801741077777
• Combination Product (Y/N): N
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2019

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: Lay User/Patient
• Device Model Number: 365722
• Device Catalogue Number: 365722
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/02/2019
• Supplement Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 01/22/2019
• Supplement Report FDA Received Date: 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1