MAUDE Adverse Event Report: HALYARD HEALTH, INC. HALYARD STERLING; SPECIALTY -TESTED FOR USE WITH CHEMOTHERAPY - PATIENT EXAMINATION GLOVE

Catalog Number 50706

Device Problems Hole In Material (1293); Material Integrity Problem (2978)

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

Event Date 08/29/2017

Event Type  malfunction  

Event Description

Halyard sterling nitrile powder free exam gloves, size small, ref 50706 have visible 'weak' areas on one or more fingers of the gloves.Not every glove is affected although a majority of random gloves throughout the box have these 'weak' areas and several create holes or tear as user is inserting hand into the glove.Currently have (2) boxes of this same lot affected.Currently no issues reported with the other sizes of halyard gloves.

• Brand Name: HALYARD STERLING
• Type of Device: SPECIALTY -TESTED FOR USE WITH CHEMOTHERAPY - PATIENT EXAMINATION GLOVE
• Manufacturer (Section D): HALYARD HEALTH, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6878539
• MDR Text Key: 86756528
• Report Number: 6878539
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 50706
• Device Lot Number: SP7143ZZZ_08AX
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/07/2017
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1