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

Device Problems Break (1069); Material Separation (1562)

Patient Problem Irritation (1941)

Event Type  malfunction  

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 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 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.

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
• Type of Device: SILICONE COUDE FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7800571
• MDR Text Key: 117852232
• Report Number: 1018233-2018-03679
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741025327
• UDI-Public: (01)00801741025327
• Combination Product (y/n): N
• PMA/PMN Number: K984136
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1