MAUDE Adverse Event Report: COVIDIEN DOVER SILICON COATED LATEX FOLEY CATHETER, 28 FR 30CC BALLOON; CATHETER, RETENTION TYPE, BALLOON

Model Number 29217 041

Device Problems Deflation Problem (1149); Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/18/2018

Event Type  Injury  

Event Description

Using dover silicon coated latex foley catheter.The balloon has deflated on 5 different catheters.A deflated balloon causes urine to leak and bleeding to occur in the bladder as the catheter moves around.

• Brand Name: DOVER SILICON COATED LATEX FOLEY CATHETER, 28 FR 30CC BALLOON
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 8196706
• MDR Text Key: 131704140
• Report Number: MW5082572
• Device Sequence Number: 3
• Product Code: EZL
• UDI-Device Identifier: 10884521016880
• UDI-Public: (01)10884521016880
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/20/2018
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/08/2023
• Device Model Number: 29217 041
• Device Lot Number: 8130K28QX
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/24/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Weight: 61