MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; FOLEY CATHETER TRAY

Catalog Number URO170516S

Device Problems Physical Resistance (2578); Difficult to Advance (2920)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

It was reported that while inserting the catheter, there were issues of meeting resistance and difficulty advancing the catheter.The patients had pre-existing urological issues that were not defined.It is unknown if it was the same clinician or the same unit that had difficulty with this catheter.We have not been made aware of any serious injury.The sample has not been returned for evaluation.A root cause has not been determined.Due to the reported incident and in an abundance of caution, this medwatch is being filed.

Event Description

It was reported that during insertion of the catheter, there were issues of meeting resistance and having difficulty advancing the catheter.

• Type of Device: FOLEY CATHETER TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• Manufacturer Contact: diane christensen ; one medline place; mundelein, IL 60060 ; 8476434747
• MDR Report Key: 5614716
• MDR Text Key: 43876900
• Report Number: 1417592-2016-00048
• 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: 04/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Catalogue Number: URO170516S
• Device Lot Number: 15OB0960
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Date Manufacturer Received: 03/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2015
• 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