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

Catalog Number DYND160516

Device Problems No Device Output (1435); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

It was reported that in 2016, the facility had three incidents of a foley catheter being placed in a male patient with no urine return.The catheter was replaced.The exact dates of these incidents are unknown.It was reported that these incidents occurred in 2016.It is unknown if the 3 incidents involved the same or different male patients.The account was unable to provide details regarding each incident other than in one incident, it is suspected that the catheter tubing was entangled in a wheelchair wheel.The samples have not been returned for evaluation.A root cause has not been determined, however due to the reported incident and in an abundance of caution this medwatch is being filed.

Event Description

It was reported that in 2016, the facility had three incidents of a foley catheter being placed in a male patient with no urine return.The catheter was replaced.

• Type of Device: FOLEY CATHETER
• 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: 5703020
• MDR Text Key: 46695229
• Report Number: 1417592-2016-00061
• 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: 06/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Catalogue Number: DYND160516
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Date Manufacturer Received: 05/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2016
• 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