MAUDE Adverse Event Report: CARDINAL HEALTH (THAILAND) 222 LIMITED GLOVE SURGICAL PROTEXIS PI; SURGEON'S GLOVES

Model Number	2D72PT80X
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer reported that there had been an issue in the theatre on (b)(6) 2026.The surgeon had just cut into the patient to insert scope (laparscopically).The surgeon had used a cardinal glove, and the glove was reported to feel sticky when wet.The surgeon had been handling the scope, and the glove had stuck to the scope.The surgeon had moved his hand, and the glove ripped resulting in a small piece of glove falling into patient¿s abdomen.It had not been recovered despite extensive searching.No further information was provided.
Additional Manufacturer Narrative
An investigation is currently in progress.A follow-up report will be filed once the results have been completed.

• Brand Name: GLOVE SURGICAL PROTEXIS PI
• Common Device Name: SURGEON'S GLOVES
• Manufacturer (Section D): CARDINAL HEALTH (THAILAND) 222 LIMITED; 7/111 moo 4 highway #331, maby; rayong 21140 ; TH 21140
• 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: 25698484
• Report Number: 1423537-2026-00216
• Device Sequence Number: 15903855
• Product Code: KGO
• UDI-Device Identifier: 10885380031960
• UDI-Public: (01)10885380031960(17)280531(10)TS25060057
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K110272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2026

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 Model Number: 2D72PT80X
• Device Catalogue Number: 2D72PT80X
• Device Lot Number: TS25060057
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2026
• Supplement Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2025
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown