MAUDE Adverse Event Report: CARDINAL HEALTH ESTEEM STRETCHY NITRILE GLOVES

Catalog Number 8816NB

Device Problem Product Quality Problem (1506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2017

Event Type  malfunction  

Event Description

New gloves repeatedly ripping when taken out of box and worn. Staff report several similar incidents related to this brand of glove. Ripped gloves are discarded. New gloves are utilized. No reports of patient or staff harm as a result of the weak gloves have been made. Specific patient not applicable.

• Brand Name: ESTEEM
• Type of Device: STRETCHY NITRILE GLOVES
• Manufacturer (Section D): CARDINAL HEALTH; mcgaw park IL 60085
• MDR Report Key: 7100903
• MDR Text Key: 94408954
• Report Number: MW5073845
• Device Sequence Number: 1
• Product Code: LZC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/06/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 8816NB
• Device Lot Number: 7F17D508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage