MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CATHETER,FOLEY,100%SILICONE,20FR,10ML,LF

Catalog Number	DYND11504
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the urinary catheter balloon deflated while inserted into a suprapubic site and the device came out of the end-user.The end-user was taken to a local hospital emergency department (ed) for evaluation and treatment.A urologist at the local hospital was unable to insert a new urinary catheter into the suprapubic site.A urinary catheter was, instead, inserted into the end-user through the urethra.Reportedly, the urologist also inserted and sutured a "wire tube" into the suprapubic site to maintain its patency.On (b)(6) 2019 the end-user reportedly received an outpatient procedure to "re-establish" the suprapubic site and a new urinary catheter was inserted into the patient through this site.No sample was returned to the manufacturer for evaluation.A root cause for the reported incident could not be determined.Due to the reported need for medical intervention, 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 balloon deflated while inserted into a suprapubic site.

• Common Device Name: CATHETER,FOLEY,100%SILICONE,20FR,10ML,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 9185967
• Report Number: 1417592-2019-00164
• Device Sequence Number: 2972845
• Product Code: EZL
• UDI-Device Identifier: 10080196845521
• UDI-Public: 10080196845521
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/14/2019

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: Lay User/Patient
• Device Catalogue Number: DYND11504
• Device Lot Number: (10)59219040441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 10/14/2019
• 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 Weight: 66