MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC PROTEXIS; SURGEONS GLOVES

Model Number 2D72PT65X

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 09/19/2019

Event Type  malfunction  

Event Description

Surgical assistants top 6.5 protexis pi glove shredded, ripped in numerous places while holding retractors.Bottom glove remained intact, no break in sterility.

• Brand Name: PROTEXIS
• Type of Device: SURGEONS GLOVES
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 9529918
• MDR Text Key: 173021691
• Report Number: 9529918
• Device Sequence Number: 1
• Product Code: KGO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2D72PT65X
• Device Catalogue Number: 2D72PT65X
• Device Lot Number: TS19050227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/26/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1