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

Model Number	806518
Medical Device Problem Code	Material Invagination (1336)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Patient Problem/Medical Problem (2688)
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 silicone catheter mushroomed during use.The patient allegedly experienced self-limited bleeding.No medical intervention/patient injury reported.
Additional Manufacturer Narrative
This report is being submitted past the regulatory timeframe.Please see attached letter for additional information.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: "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 of 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.
Event or Problem Description
It was reported that the balloon of the silicone catheter mushroomed during use.The patient allegedly experienced self-limited bleeding.No medical intervention/patient injury reported.

• Brand Name: BARDIA® ALL-SILICONE FOLEY CATHETER
• Common Device Name: SILICONE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8490005
• Report Number: 1018233-2019-01758
• Device Sequence Number: 1104395
• Product Code: EZL
• UDI-Device Identifier: 00801741039188
• UDI-Public: (01)00801741039188
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• 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): 05/29/2019

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: 806518
• Device Catalogue Number: 806518
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/15/2019
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 04/07/2019
• Supplement Report FDA Received Date: 05/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1