MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER; SILICONE COUDE FOLEY CATHETER

Model Number	0170SI12
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Irritation (1941)
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 information provided by bard 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 bard.
Event or Problem Description
It was reported that the tip of the catheter separated from the balloon upon removal of the catheter.At this time it is unknown if any pieces of the catheter were left behind.Per follow up with the patient by phone on (b)(6) 2018 it was reported that the patient has experienced bladder irritation and has not contacted a physician at this time.There has been no medical intervention.
Event or Problem Description
It was reported that the tip of the catheter separated from the balloon upon removal of the catheter.At that time it was unknown if any pieces of the catheter were left behind.Per follow up with the patient by phone on (b)(6) 2018 it was reported that the patient had experienced bladder irritation and had not contacted a physician at that time.There was no medical intervention.
Additional Manufacturer Narrative
The reported event was confirmed.The evaluation of the photo sample indicated that the balloon was separated from the shaft.No further evaluation was possible without the original sample or a more clear photo sample.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 petrolatum base.They will damage silicone and may cause the balloon to burst." section a through f - the information provided by bard 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 bard.

• Brand Name: BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER
• Common Device Name: SILICONE COUDE FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7800571
• Report Number: 1018233-2018-03679
• Device Sequence Number: 13846398
• Product Code: MJC
• UDI-Device Identifier: 00801741025327
• UDI-Public: (01)00801741025327
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K984136
• 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): 11/06/2018

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: Lay User/Patient
• Device Model Number: 0170SI12
• Device Catalogue Number: 0170SI12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Initial Date Received by Manufacturer: 07/30/2018
• Supplement Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 11/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1