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

Model Number 2D73PM65

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/02/2019

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 208398736
• Report Number: 1423537-2019-00365
• Device Sequence Number: 1
• Product Code: KGO
• UDI-Device Identifier: 10885380031786
• UDI-Public: 10885380031786
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2D73PM65
• Device Catalogue Number: 2D73PM65
• Device Lot Number: TS18080142
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Weight: 84