MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. FOLEY CATHETER 14F; CATHETER, RETENTION TYPE

Device Problems Break (1069); Crack (1135); Leak/Splash (1354)

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

Event Date 12/24/2018

Event Type  Injury  

Event Description

The pt received a foley for urinary retention.Approx.2 hrs after insertion, pt was up on side of bed working with physical therapy.Therapist noted leak and report it to nursing staff.This rn assessed foley.I noted a crack in the foley chamber, between the connection tubing and hard plastic.With minimal maneuvering the plastic broke off.New foley placed.Dates of use: (b)(6) 2018, diagnosis or reason for use: urinary retention; (b)(4).

• Brand Name: FOLEY CATHETER 14F
• Type of Device: CATHETER, RETENTION TYPE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 8277797
• MDR Text Key: 134343805
• Report Number: MW5083375
• 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: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 78