MAUDE Adverse Event Report: C.R. BARD, INC. FOLEY CATHETER 3-WAY FOLEY; CATHETER, RETENTION TYPE, BALLOON

Lot Number NGEV4130

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/01/2020

Event Type  Injury  

Event Description

A 20 french council tip three-way foley catheter was pulled out by the patient.The nurse recognized the distal end was not complete and therefore retained.Patient scoped and revealed coudé tip, balloon complete and approximately 3 cm of shaft of foley catheter.Fda safety report id # (b)(4).

• Brand Name: FOLEY CATHETER 3-WAY FOLEY
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C.R. BARD, INC. ; covington GA 30014
• MDR Report Key: 11108061
• MDR Text Key: 225062264
• Report Number: MW5098624
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: NGEV4130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 76