MAUDE Adverse Event Report: CARDINAL HEALTH PROTEXIS PI STERILE GLOVES

Lot Number TS14060555

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 10/27/2014

Event Type  malfunction  

Event Description

The sterile gloves had an unidentified foreign material stuck to the inside of the right glove.Diagnosis or reason for use: to prepare iv's.

• Brand Name: PROTEXIS PI STERILE GLOVES
• Type of Device: STERILE GLOVES
• Manufacturer (Section D): CARDINAL HEALTH
• MDR Report Key: 4217217
• MDR Text Key: 4968627
• Report Number: MW5038872
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 10/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2017
• Device Lot Number: TS14060555
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1