MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC; FOLEY CATHETER

Catalog Number URO170716

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

The nurse placed the catheter and attempted to fill the balloon with water, as she did so the water spilled out of the catheter.It was noted there was a slit at the bifurcation of the catheter.The catheter had to be discontinued and a new one inserted.The sample was returned and investigated.A visual inspection of the catheter confirmed the complaint.There is no definitive root cause at this time.Due to the re-insertion of the foley catheter this medwatch is being filed.

Event Description

Foley catheter was inserted and a slit at the bifurcation below the inflation valve leaked requiring a new catheter to be inserted.

• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): MEDLINE INDUSTRIES INC; one medline place; mundelein IL 60060
• Manufacturer Contact: megan debus ; one medline place; mundelein, IL 60060 ; 8477703962
• MDR Report Key: 6138062
• MDR Text Key: 61229599
• Report Number: 1417592-2016-00119
• Device Sequence Number: 1
• Product Code: OHR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: URO170716
• Device Lot Number: 16SB1903
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other