MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS, LP; SORBAVIEW SHIELD SYS 2.25" X 2.75" ST

Catalog Number	SV226UDT
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility on (b)(6) 2024 during a sedated mri, the patient had a peripheral iv in place for a sedated mri.The peripheral iv was dressed in sorbaview shield micro by centurion (ref sv226udt).During the scan, the patient started to move, hold her breath, and have oxygen desaturations.The sedated mri team stopped the scan and found that the patient's iv was no longer patent due to the structure of the dressing.
Additional Manufacturer Narrative
According to the facility on (b)(6) 2024 during a sedated mri, the patient had a peripheral iv in place for a sedated mri.The peripheral iv was dressed in sorbaview shield micro by centurion (ref sv226udt).During the scan, the patient started to move, hold her breath, and have oxygen desaturations.The sedated mri team stopped the scan and found that the patient's iv was no longer patent due to the structure of the dressing.The hub of the extension tubing was secured by the dressing but the transparent film of the dressing was not tight nor had enough adhesive and the catheter hub was able to twist, partially pull out, and kink where it met the skin.This caused the anesthesia medication to leak out of the site and the patient was no longer receiving enough anesthetic.The patient became agitated and started exhibiting signs of respiratory distress including breath-holding, low oxygen saturations, and retractions.The anesthesia provider attempted 3 more times to place a new peripheral iv with success on the 3rd attempt.The patient however was unable to calm enough to be still and maintain respiratory status due to the circumstances.The patient's scan had to be terminated due to concerns about the patient's airway and oxygenation and will likely need to be repeated another day.Due to this patient's prematurity at birth, this patient requires a 12-hour stay after receiving anesthesia and will likely need another 12 hour stay with rescheduling the exam.This patient also exhibited signs of respiratory stress during her anesthesia recovery and required extra suctioning and nebulized medication.The sample is not available for evaluation.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: SORBAVIEW SHIELD SYS 2.25" X 2.75" ST
• 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: 21170200
• Report Number: 1824619-2025-00001
• Device Sequence Number: 9475290
• Product Code: KMK
• UDI-Device Identifier: 20653160253898
• UDI-Public: 20653160253898
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 01/16/2025

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: SV226UDT
• Device Lot Number: 2024080801
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 6 MO
• Patient Sex: Female
• Patient Weight: 6 KG