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

Model Number	2D72NT70X
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record for the reported lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.A photo received showed one glove with a cuff tear only.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 of glove tear or glove torn into two pieces.As such, a root cause could not be determined.We will continue to monitor related reports to determine if additional actions are necessary.
Event or Problem Description
Customer reported that per the surgeon, one glove tore apart and made a hole when put on.Another pair tore into two pieces where the rolled edge tore off completely but this was not documented and there was no sample or photo of this.It could be seen at the break point that the rubber was thinner.There was no patient harm.

• Brand Name: PROTEXIS
• Common Device Name: SURGEON'S GLOVES
• Manufacturer (Section D): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; 7/111 moo 4 highway #331, maby; rayong IL 21140 ; TH 21140
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 21903940
• Report Number: 1423537-2025-00179
• Device Sequence Number: 19848460
• Product Code: KGO
• UDI-Device Identifier: 10885380031694
• UDI-Public: (01)10885380031694(17)250430(10)TS22050248
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 04/24/2025

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 Expiration Date: 04/30/2025
• Device Model Number: 2D72NT70X
• Device Catalogue Number: 2D72NT70X
• Device Lot Number: TS22050248
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 04/24/2025
• 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
• Patient Sex: Unknown