MAUDE Adverse Event Report: CARDINAL HEALTH CARDINAL HEALTH; GLOVES, ESTEEM STRETCHY NITRILE II LIGHT BLUE

Model Number ESTEEM STRETCHY

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

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

Event Type  malfunction  

Event Description

Foreign matter in esteem stretchy nitrile ii light blue gloves from cardinal health.Dates of use: (b)(6) 2015.

• Brand Name: CARDINAL HEALTH
• Type of Device: GLOVES, ESTEEM STRETCHY NITRILE II LIGHT BLUE
• Manufacturer (Section D): CARDINAL HEALTH; 1430 waukegan rd; mcgaw park IL 60085
• MDR Report Key: 4884048
• MDR Text Key: 6265222
• Report Number: MW5043408
• 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: Other
• Type of Report: Initial
• Report Date: 06/23/2015

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: Health Professional
• Device Model Number: ESTEEM STRETCHY
• Device Catalogue Number: 8813N5
• Device Lot Number: 8D14N003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/24/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1