MAUDE Adverse Event Report: BARD/C.R. BARD, INC. BARD FOLEY CATHETER INSERTION KIT; CATHETER, RETENTION TYPE, BALLOON

Model Number 1968924432AC0117040

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2022

Event Type  Injury  

Event Description

Pt was catheterized with bard unitary catheter.Upon removal- the foley would not come out-and the surgeon removed it.The catheter was in an accordion shape along the shaft.

• Brand Name: BARD FOLEY CATHETER INSERTION KIT
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): BARD/C.R. BARD, INC.
• MDR Report Key: 14254107
• MDR Text Key: 290653335
• Report Number: MW5109420
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1968924432AC0117040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White