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

Model Number	2D72PT65X
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	06/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record of the complaint lot was reviewed.The lot was inspected and released in compliance with all requirements.Because the complaint sample and photo are not available for evaluation, a review of the physical properties trending found tensile strength and cuff, palm, finger thickness were within our specification, therefore an exact root cause could not be determined for this case.The complaint information was informed to the relevant sectors for their awareness.There is no action taken at this time, but we will continue to monitor the trend of this type of incident.
Event or Problem Description
It was reported that during an orthopedic surgery, the surgeon¿s glove tore causing him contact with the patient's blood which was positive for (b)(6).The surgeon performed immediate cleaning and disinfection of the skin area in contact with blood.Minimal delay in procedure.The surgeon did not require follow up lab testing or medications.No injury reported to the patient.No further issues reported from surgeon.

• 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
• MDR Report Key: 10286067
• Report Number: 1423537-2020-00483
• Device Sequence Number: 14276264
• Product Code: KGO
• UDI-Device Identifier: 10885380031939
• UDI-Public: 10885380031939
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/16/2020

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: 2D72PT65X
• Device Catalogue Number: 2D72PT65X
• Device Lot Number: TS19090157
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2020
• Initial Report FDA Received Date: 07/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other