MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC PROTEXIS; SURGEON'S GLOVES

Model Number	2D72NT80X
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently in progress.A follow-up report will be filed once the results have been completed.
Event or Problem Description
Customer reported that the tip of the little finger of the left glove was torn.The missing piece was not there.No further information was provided.
Additional Manufacturer Narrative
The device history records of the complaint lot was reviewed.The lot was inspected and released in compliance with all requirements.Prior to a lot¿s release, the lot must be deemed acceptable by passing inspections that are based on a valid sampling plan.During production, inspectors routinely examine a statistical sample both physically and visually.There were no samples returned for evaluation; therefore, the affected device could not be evaluated to confirm the reported failure.As such, a root cause could not be determined.We will continue to monitor related reports to determine if additional actions are necessary.
Additional Manufacturer Narrative
The device history record of the complaint lot was reviewed.The lot was inspected and released in compliance with all requirements.The sample was returned and evaluated by visual and physical inspection and the reported issue was observed.The potential root cause was due to the glove hitting a sharp edge of the auto strip machine.A routine machine equipment inspection program has been established and implemented to identify any tearing defects from normal operation.We will continue to monitor related reports to determine if additional actions are necessary.

• Brand Name: PROTEXIS
• Common Device Name: SURGEON'S GLOVES
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH (THAILAND) 222 LIMITED; 7/111 moo 4 highway #331, maby; rayong 21140 ; TH 21140
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 22866243
• Report Number: 1423537-2025-00338
• Device Sequence Number: 21166794
• Product Code: KGO
• UDI-Device Identifier: 10885380031717
• UDI-Public: (01)10885380031717(11)240718(17)270630(10)TS24070193
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K001924
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/10/2025

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: 2D72NT80X
• Device Catalogue Number: 2D72NT80X
• Device Lot Number: TS24070193
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 09/04/2025; 10/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown