MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; BAG,LEG,EX-TUBING,18,MEDIUM,20OZ

Catalog Number	URO12575
Medical Device Problem Code	Appropriate Term/Code Not Available (3191)
Health Effect - Clinical Code	Urinary Retention (2119)
Date of Event	10/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, the leg bags "vacuumed shut" causing "no urine drainage".
Additional Manufacturer Narrative
According to the customer, the leg bags "vacuumed shut" causing "no urine drainage".The customer reported the individual required and emergency department visit for "urine retention".The customer reported an additional foley catheter was placed and "they did well after the ed visit".The customer did not report any serious injury.Sample requested for return evaluation.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: BAG,LEG,EX-TUBING,18,MEDIUM,20OZ
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18133755
• Report Number: 1417592-2023-00447
• Device Sequence Number: 6902890
• Product Code: KNX
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/14/2023

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?: No
• Device Catalogue Number: URO12575
• Device Lot Number: 96923060001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown