MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC; FOLEY CATHETER

Catalog Number URO170516S

Device Problem Detachment Of Device Component (1104)

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

Event Date 11/30/2016

Event Type  Injury  

Manufacturer Narrative

During an open colectomy surgery the patient's foley catheter fell out.Upon inspection operating room staff noted the balloon had burst.It is unknown when the catheter was inserted or how long it had been in place.No injury occurred but a new foley catheter had to be inserted.The catheter was returned for investigation and showed urine with sediment and encrustation in the collection bag and a jagged tear in the retention balloon.The reported issue of a torn/burst balloon was verified by visual inspection of the received sample.The root cause for the tear cannot be determined, it is unknown if external forces contributed to the tear.Due to a new foley catheter being inserted this medwatch is being filed.

Event Description

It was reported that a catheter fell out during a procedure.

• 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: 6215549
• MDR Text Key: 63636254
• Report Number: 1417592-2016-00124
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Catalogue Number: URO170516S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 12/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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