MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TRAY,FOLEY,100% SILICONE,16FR,10ML,LF

Catalog Number	DYND11519
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that after being inserted into the patient, the urinary catheter balloon would not inflate.According to the reporting facility, the urinary catheter balloon was not pre-inflated prior to being inserted into the patient.When the reported product issue was identified, the urinary catheter was removed and a new urinary catheter was inserted.No further incident or adverse patient impact was reported to the manufacturer.The urinary catheter involved in this incident was discarded and unavailable to be returned to the manufacturer for evaluation.A root cause for the reported incident was unable to be determined.Due to the reported need for medical intervention to remove and replace the urinary catheter, 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 after being inserted into the patient, the urinary catheter balloon would not inflate.

• Common Device Name: TRAY,FOLEY,100% SILICONE,16FR,10ML,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 9440067
• Report Number: 1417592-2019-00225
• Device Sequence Number: 11456634
• Product Code: OHR
• UDI-Device Identifier: 10080196809790
• UDI-Public: 10080196809790
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/09/2019

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: Health Professional
• Device Catalogue Number: DYND11519
• Device Lot Number: 96919040002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2019
• Initial Report FDA Received Date: 12/09/2019
• 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