MAUDE Adverse Event Report: MEDLINE INDUSTRIES; FOLEY CATHETER

Catalog Number DYND160416

Device Problem Physical Resistance (2578)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

The account stated the catheters are difficult to insert and are causing trauma to patients.The nurse felt resistance when inserting the catheter, extra lubrication was used prior for insertion.Once inserted there was very little urine output from the catheter.It was decided to remove the catheter.The nurse had difficulty pulling the catheter out, and bleeding from the meatus was noted.The balloon was fully drained prior to removal of catheter.The sample was not returned and a root cause cannot be determined.Due to the reported incident and in an abundance of caution this medwatch is being filed.

Event Description

It was reported there was resistance with insertion and discontinuing a foley catheter.

• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): MEDLINE INDUSTRIES; three lakes drive; northfield IL 60093
• Manufacturer Contact: megan debus ; three lakes drive; northfield, IL 60093 ; 8477703962
• MDR Report Key: 6383435
• MDR Text Key: 69254958
• Report Number: 1417592-2017-00009
• 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: 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Catalogue Number: DYND160416
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 34 YR