MAUDE Adverse Event Report: CARDINAL HEALTH INC. ESTEEM XP NITRILE; PATIENT EXAMINATION GLOVE

Catalog Number N8853XP

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2014

Event Type  malfunction  

Event Description

Gloves were pulled out of the box without difficulty and put on.A hole was in the thumb of the gloves.No harm to patient or staff.Hole was visibly evident.Another glove obtained and care continued.This facility has had multiple similar events with this device/product within a two month time span.The manufacturer has been notified and is testing the device/product.

• Brand Name: ESTEEM XP NITRILE
• Type of Device: PATIENT EXAMINATION GLOVE
• Manufacturer (Section D): CARDINAL HEALTH INC.; 1430 waukegan rd-mpkb-2b; mcgaw park IL 60085
• MDR Report Key: 3672174
• MDR Text Key: 21314816
• Report Number: 3672174
• Device Sequence Number: 1
• Product Code: LZC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 02/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: N8853XP
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/05/2014
• Event Location: Hospital
• Date Report to Manufacturer: 03/11/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 7 YR
• Patient Weight: 29