MAUDE Adverse Event Report: HALYARD HEALTH, INC. HALYARD QUICK CHECK; WRAP, STERILIZATION

Model Number 34147

Device Problem Material Separation (1562)

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

Event Date 11/22/2016

Event Type  malfunction  

Event Description

Sterile processing technician went to use the sterilization wrap to prepare surgical trays for sterilization when they noticed the wrap's top layer was coming apart from the bottom layer of the wrap.This caused a delay in sterilizing the trays since they had to find wrap that worked.Manufacturer response for sterilization wrap 48x48, halyard* quick check* sterilization wrap (per site reporter): they have sent in replacement product and want to pick up the affected lot.

Event Description

Sterile processing - technician went to use the sterilization wrap to prepare surgical trays for sterilization when they noticed the wrap's top layer was coming apart from the bottom layer of the wrap.This caused a delay in sterilizing the trays since they had to find wrap that worked.Manufacturer response for sterilization wrap 48x48, halyard quick check sterilization wrap (per site reporter): they have sent in replacement product and want to pick up the affected lot.

• Brand Name: HALYARD QUICK CHECK
• Type of Device: WRAP, STERILIZATION
• Manufacturer (Section D): HALYARD HEALTH, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6185055
• MDR Text Key: 62717024
• Report Number: 6185055
• Device Sequence Number: 1
• Product Code: FRG
• 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,Followup
• Report Date: 11/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 34147
• Device Catalogue Number: 34147
• Device Lot Number: LT6288000
• Other Device ID Number: 48X48
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/23/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/23/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1