MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CATHETER,FOLEY,100%SILICONE,24FR,10ML,LF

Catalog Number	DYND11506H
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the customer is a home health patient who used catheters for chronic issues and stores the catheters in the sterile packaging in a plastic 3 tied storage device in her home.(b)(6) reported that the balloons of the catheter are pre-inflated prior to insertion however the leaking was noted in the tubing, not the balloon.There was a hole toward the end of 1 tubing near the area where it connects to another tube.The case manager reported that the catheter was placed on (b)(6) 2019 and the hole was noticed on (b)(6) 2020.The case manager stated that that she is unsure if the incident occurred because of the bag that they were using with the catheter.The customer didn't have the 2000ml bag because it was reportedly on back order, so she used the 4000ml bag instead and because she is ambulatory she may have created a risk of the tubing developing a hole.Upon noticing wet clothing the interim nurse was called and came to the home to replace the catheter.The actual sample was disposed of and is not available to be returned for evaluation.There is no additional information available.Due to the reported incident, 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 urinary catheter tube got a hole in it and needed to be replaced.The urinary catheter was removed and replaced.

• Common Device Name: CATHETER,FOLEY,100%SILICONE,24FR,10ML,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 9580717
• Report Number: 1417592-2020-00003
• Device Sequence Number: 19668351
• Product Code: EZL
• UDI-Device Identifier: 10080196848829
• UDI-Public: 10080196848829
• 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): 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYND11506H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 01/13/2020
• 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: 54 YR
• Patient Weight: 84