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

Model Number	2D73PM65
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/02/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Based on information received from the customer, the glove fingertip tore on the protexis pi classic glove during dr.(b)(6) procedure.The glove fingertip was reportedly retrieved in the patient¿s cavity.Per the customers information there was no adverse effects to the surgeon or the patient.
Additional Manufacturer Narrative
A thorough investigation into the reported issue was conducted and the root cause of the reported problem was found to be related to the use of an additional/alternate supplier of the polyisoprene.The additional supplier was used so that there would not be just a single source supplier.Although the alternate supplier¿s product did meet specification, the investigation revealed that the original supplier¿s tear resistance was stronger for the same thickness control.As of october 2018 cardinal health reverted back to using only the original supplier.The device history record of the complaint lot was reviewed and the lot was inspected and released in compliance with all requirements.The lot number reported in this incident was produced prior to the corrective action of reverting back to the original supplier of the polyisoprene.We continue to monitor complaints for any trends, and to ensure that reverting back to the original supplier has resolved the issue.

• 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: 9233485
• Report Number: 1423537-2019-00365
• Device Sequence Number: 16650637
• Product Code: KGO
• UDI-Device Identifier: 10885380031786
• UDI-Public: 10885380031786
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2D73PM65
• Device Catalogue Number: 2D73PM65
• Device Lot Number: TS18080142
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/02/2019
• Supplement Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 09/11/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR
• Patient Weight: 84