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

Model Number	2D73PM65
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	09/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was not available; therefore, the device history record could not be reviewed.The sample and photo were not available for evaluation.The exact root cause could not be determined without a sample, however, a possible root cause for this reported issue may come from improper coating during the dipping process.We will continue to monitor the complaints for any unfavorable trends, which might require further investigation and action plan.The manufacturing plant has been advised of this reported incident for close monitoring of the manufacturing process.
Event or Problem Description
Based on information received by the customer, ¿per employee, as i was holding pressure on a groin with an arterial and venous sheath in place, my glove had a hole in it, which i discovered 10 minutes into the hold.The site was actively bleeding.When i removed my glove, my whole hand was covered in the patient's blood.I have a few small cuts and rough cuticles on my hand." additional information provided by the customer: source patient (b)(6) antibody (b)(6).Employee received routine post exposure counseling.Employee is fine.No further monitoring required since (b)(6).

• Brand Name: GLOVE SURGICAL PROTEXIS PI MICRO
• 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: 9198635
• Report Number: 1423537-2019-00361
• Device Sequence Number: 11302368
• Product Code: KGO
• UDI-Device Identifier: 10885380027277
• UDI-Public: 10885380027277
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 10/16/2019

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: 2D73PM65
• Device Catalogue Number: 2D73PM65
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 10/16/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Weight: 59