MAUDE Adverse Event Report: C. R. BARD, INC. BARDEX® LUBRI-SIL® ALL-SILICONE TEMP SENSING FOLEY CATHETER; CATHETER, RETENTION TYPE, BALLOON

Model Number 119216M

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/05/2019

Event Type  malfunction  

Event Description

Patient returned from open heart surgery at 7:30 am and foley catheter noted to be in bed a while later.Rn checked foley and noted that there was a pin size hole in the silicone foley balloon.Using a 2 person foley insertion technique, a new foley was placed in sicu.Manufacturer response for catheter, retention type, balloon, bardex® lubri-sil® all-silicone temp sensing foley catheter (per site reporter).Awaiting response.The device will be returned for failure analysis.

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE TEMP SENSING FOLEY CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial boulevard; covington GA 30014
• MDR Report Key: 9495673
• MDR Text Key: 172024593
• Report Number: 9495673
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741046308
• UDI-Public: (01)00801741046308
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/23/2019

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
• Device Operator: No Information
• Device Model Number: 119216M
• Device Catalogue Number: 119216M
• Device Lot Number: NGDP2428
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/23/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22995 DA
• Patient Weight: 83