MAUDE Adverse Event Report: CARDINAL HEALTH PROTEXIS PI; POWDERED LATEX SURGEON'S GLOVES

Model Number 2D72PT75X

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/12/2017

Event Type  malfunction  

Event Description

Tip of glove found in patient's chest wall status post (s/p) chest tube placement when patient had a thoracoscopy with bleb resection 5 days later.No patient harm.

Event Description

Tip of glove found in patient's chest wall status post (s/p) chest tube placement when patient had a thoracoscopy with bleb resection 5 days later.No patient harm.

• Brand Name: PROTEXIS PI
• Type of Device: POWDERED LATEX SURGEON'S GLOVES
• Manufacturer (Section D): CARDINAL HEALTH; 785 fort mill hwy.; fort mill SC 29707
• MDR Report Key: 6568667
• MDR Text Key: 75257671
• Report Number: 6568667
• Device Sequence Number: 1
• Product Code: KGO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 04/11/2017,05/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/31/2019
• Device Model Number: 2D72PT75X
• Device Catalogue Number: 2D72PT75X
• Device Lot Number: TS16110146
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/11/2017
• Event Location: Hospital
• Date Report to Manufacturer: 04/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 39 YR