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

Model Number	A800361
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)
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 when the foley catheter was removed from the patient, there was a tear on the balloon area.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event was confirmed as cause unknown.The evaluation found a sac burst along the lumen.The sample was evaluated under a microscope and no conditions were found that could be associated with the reported event.The exact cause could not be determined.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 when the foley catheter was removed from the patient, there was a tear on the balloon area.No medical intervention was reported.

• Brand Name: BARD® LUBRICATH® FOLEY CATHETER
• Common Device Name: HYDRO GEL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8228947
• Report Number: 1018233-2019-00163
• Device Sequence Number: 204213
• Product Code: EZC
• UDI-Device Identifier: 00801741073939
• UDI-Public: (01)00801741073939
• 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: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2019

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: Health Professional
• Device Expiration Date: 04/01/2023
• Device Model Number: A800361
• Device Catalogue Number: 365716
• Device Lot Number: 8EJ7121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Initial Date Received by Manufacturer: 12/17/2018
• Supplement Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 01/08/2019
• Supplement Report FDA Received Date: 05/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1