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

Model Number	265722
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
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 several of the foley catheters got clogged so patient had to go to the emergency room to get it changed.
Event or Problem Description
It was reported that several foley catheters got clogged so patient had to go to the emergency room to get it changed.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned for evaluation.A potential root cause for this failure could be user related (example: salt accumulation)/ block drainage lumen/ no drainage eye.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: warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage latex and may cause balloon to burst.Visually inspect the product for any imperfections or surface deterioration prior to use.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.H3 other text : the device was not returned.

• Brand Name: BARD FOLEY CATHETER SILICONE COATED
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11422291
• Report Number: 1018233-2021-01007
• Device Sequence Number: 14393908
• Product Code: EZC
• UDI-Device Identifier: 00801741039621
• UDI-Public: (01)00801741039621
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2021

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: 265722
• Device Catalogue Number: 265722
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 03/05/2021
• Supplement Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other