MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TRAY,FOLEY,CATH,SIL-ELAST,16FR,10ML,BG

Catalog Number	DYND11003H
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that, while inserted in patient, the foley catheter's balloon deflated resulting in the foley catheter falling out from the patient.Per report, the patient is a home health patient and required the foley catheter due to being a paraplegic.The foley catheter was placed in the patient on (b)(6) 2018 by her home health nurse and on (b)(6) 2018 the patient noticed that the catheter fell out.The customer reported that when she inspected the balloon it looked like the balloon popped.The patient contacted her home health nurse and a new catheter was placed without further incident.There was no further change to the patient's treatment plan at this time.There was no serious injury or follow up care reported related to the event.There was no report of any adverse patient consequence and no effect on the patient's stability, as a result of the incident.Due to the reported need for foley catheter re-insertion and in an abundance of caution, this medwatch is being filed.The sample was returned for evaluation and the customer reported issue was confirmed; however a root cause could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that while inserted in patient, the foley catheter's balloon deflated resulting in the foley catheter falling out from the patient.

• Common Device Name: TRAY,FOLEY,CATH,SIL-ELAST,16FR,10ML,BG
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7832214
• Report Number: 1417592-2018-00085
• Device Sequence Number: 16523278
• Product Code: OHR
• UDI-Device Identifier: 10080196991471
• UDI-Public: 10080196991471
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/30/2018

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: Health Professional
• Device Catalogue Number: DYND11003H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/30/2018
• 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: Required Intervention
• Patient Age: 78 YR
• Patient Weight: 118