MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; BAG,LEG,COMFORT-STRAPS,MEDIUM,20OZ

Catalog Number	DYND12584
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the leg bag was "not draining properly" and a patient was diagnosed with urosepsis.After multiple good-faith attempts, the reporting facility was unable or unwilling to provide additional patient or product information related to this report.No diagnostic exams, medical intervention, or follow-up care have been reported to the manufacturer.It is unknown what type of urinary catheter was used in conjunction with the leg bag and how long the urinary catheter and the leg bag was in use for prior to identifying the reported product issue.No sample was returned to the manufacturer for evaluation.A root cause for the reported product incident could not be identified.Due to the reported incident, and in an abundance of caution, 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 leg bag was "not draining properly" and a patient was diagnosed with urosepsis.

• Common Device Name: BAG,LEG,COMFORT-STRAPS,MEDIUM,20OZ
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 8280272
• Report Number: 1417592-2019-00003
• Device Sequence Number: 2462593
• Product Code: KNX
• UDI-Device Identifier: 10080196840779
• UDI-Public: 10080196840779
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/26/2019

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: DYND12584
• Device Lot Number: 96918090002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2019
• Initial Report FDA Received Date: 01/26/2019
• 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: Other