MAUDE Adverse Event Report: CARDINAL HEALTH PROTEXIS PI BLUE WITH NEU-THERA, SIZE 7.5; STERILE GLOVES

Device Problem Material Integrity Problem (2978)

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

Event Date 11/18/2015

Event Type  malfunction  

Event Description

Sterile gloves tear easily during donning for surgical procedure.Potential risk for breach in asepsis and foreign body in surgical field.

• Brand Name: PROTEXIS PI BLUE WITH NEU-THERA, SIZE 7.5
• Type of Device: STERILE GLOVES
• Manufacturer (Section D): CARDINAL HEALTH
• MDR Report Key: 5243486
• MDR Text Key: 31982687
• Report Number: MW5058021
• Device Sequence Number: 1
• Product Code: KGO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/18/2015

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
• Device Operator: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/18/2015
• Type of Device Usage: N
• Patient Sequence Number: 1