MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CATHETER,FOLEY,100%SILICONE,6FR,1.5ML,LF

Catalog Number	DYND11552
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the foley catheter was placed (b)(6) 2018 at 08:00 am and was noted to be out approximately an hour later with the balloon no longer inflated.Per report, the foley catheter was used to provide a method of re-infusing high ostomy output into a lower mucous fistula (to maintain the patency, function and encourage maturation of the distal bowel, refeeding of stoma losses from a high ostomy into a lower mucous fistula may be considered).Reportedly, prior to insertion, the balloon deflated on first test but was then tested again and stayed inflated.Upon insertion to the patient, air (not saline) approximately 1.5 ml was used to inflate the balloon and surgeon "tugged" on catheter after placement to verify securement.It was reported that immediately after the incident, the surgeon re-inserted a new foley catheter and the patient is doing well right now.There was no serious injury reported related to the incident.The facility stated that this is an off-label use of the foley catheter.The sample was returned for evaluation and the reported issue was confirmed, however this was off label use.The foley catheter performed properly when used as intended.Due to the reported incident and in abundance of caution, this medwatch is being filed.If additional relevant information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the foley catheter balloon, which was filled with air, would not hold inflation while in the patient.

• Common Device Name: CATHETER,FOLEY,100%SILICONE,6FR,1.5ML,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7448139
• Report Number: 1417592-2018-00023
• Device Sequence Number: 13796320
• Product Code: EZL
• UDI-Device Identifier: 10884389034415
• UDI-Public: 10884389034415
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Catalogue Number: DYND11552
• Device Lot Number: 59217101696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 04/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 4 MO
• Patient Weight: 3