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

Catalog Number	DYND11003
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that a home care customer had a catheter placed on the morning of (b)(6) 2018.The customer service representative reported that while the caregiver was helping the customer get ready for bed on the same night ((b)(6) 2018), the caregiver rolled the customer over and the customer felt a pain in the area of the catheter placement; however, did not know why the pain occurred.The next morning the customer noticed the catheter fell out and the balloon of the catheter appeared to be popped.The customer's caregiver was a nurse and there was another catheter that was available in the home, so the nurse replaced the catheter without further incident.The catheters are stored in the closet at the customer's home.The actual sample was returned to the manufacturer for evaluation and the customer reported issue was confirmed; however, a root cause could not be determined at this time.There was no serious injury, follow-up medical care or additional medical intervention required related to the incident; however, medical intervention to replace the foley catheter was necessary.Due to the reported need for foley catheter re-insertion and in an abundance of caution, this medwatch is being filed.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: 8055025
• Report Number: 1417592-2018-00117
• Device Sequence Number: 1406957
• 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: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/09/2018

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: DYND11003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/09/2018
• 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