MAUDE Adverse Event Report: Cardinal Health 200, LLC PROTEXIS; Surgeons gloves

Model Number	2D73PM70
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Infusion rn working in infusion lab reports that the sterile gloves we currently have in stock seem to be more fragile.4 out of 5 pair have torn very easily this am.

• Brand Name: PROTEXIS
• Common Device Name: Surgeons gloves
• Manufacturer (Section D): Cardinal Health 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 50191960
• Report Number: 50191960
• Device Sequence Number: 12292660
• Product Code: KGO
• UDI-Device Identifier: 20885380027281
• UDI-Public: (01)20885380027281
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/22/2026
• Report Date (Section F): 06/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2D73PM70
• Device Catalogue Number: 2D73PM70
• Device Lot Number: ts25020165
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/10/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/10/2026
• 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
• Date Report Sent to FDA: 06/22/2026