MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS, LP; SV SHIELD SYS., MED, ST, 3 3/4 X 5 7/16

Catalog Number	SV353UDT
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Anxiety (2328)
Date of Event	02/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, "i found the pic line on the floor and the dressing is intact.The extremely thin tubing of the device slipped under this unsuitable dressing, thus depriving the patient of her analgesics, sedative, and food.".
Additional Manufacturer Narrative
According to the customer, "i found the pic line on the floor and the dressing is intact.The extremely thin tubing of the device slipped under this unsuitable dressing, thus depriving the patient of her analgesics, sedative, and food.The patient was found to be in pain and anxious because the patient was no longer having her therapies.It led to a change in the organization of the medical and paramedical unit to try to obtain another venous line.The patient procedure was redone with difficulty." it has been determined that the reported event could cause or contribute to serious injury if it were to occur.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: SV SHIELD SYS., MED, ST, 3 3/4 X 5 7/16
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS, LP; 301 catrell drive; howell MI 48843 1703
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 19234514
• Report Number: 1824619-2024-00007
• Device Sequence Number: 12507715
• Product Code: KMK
• UDI-Device Identifier: 00653160224726
• UDI-Public: 00653160224726
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 05/02/2024

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
• Device Catalogue Number: SV353UDT
• Device Lot Number: 2023081501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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