MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; SNAPSECURE 3-WAY FOLEY DEVICE

Catalog Number	SNAPSECURE3W
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility on multiple dates, faulty clasp and stat-lock is breaking off adhesive dressing.
Additional Manufacturer Narrative
According to the facility on multiple dates, "faulty clasp and stat-lock is breaking off adhesive dressing.The foley had to be replaced for all of these instances due to the patient's having to stay in traction from the end of surgery to the following morning.This issue is causing the foleys to become clotted which is why the foleys need to be replaced.".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.
Additional Manufacturer Narrative
Update to h6: investigation conclusions.

• Common Device Name: SNAPSECURE 3-WAY FOLEY DEVICE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 19727337
• Report Number: 1417592-2024-00729
• Device Sequence Number: 20884794
• Product Code: EYJ
• UDI-Device Identifier: 20193489102717
• UDI-Public: 20193489102717
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 08/28/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: SNAPSECURE3W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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