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U.S. Department of Health and Human Services

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

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HALYARD HEALTH, INC. HALYARD QUICK CHECK WRAP, STERILIZATION Back to Search Results
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.
 
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Brand NameHALYARD QUICK CHECK
Type of DeviceWRAP, STERILIZATION
Manufacturer (Section D)
HALYARD HEALTH, INC.
5405 windward parkway
alpharetta GA 30004
MDR Report Key6185055
MDR Text Key62717024
Report Number6185055
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/23/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2016
Is this a Product Problem Report? Yes
Device Operator
Device Model Number34147
Device Catalogue Number34147
Device Lot NumberLT6288000
Other Device ID Number48X48
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/23/2016
Event Location Hospital
Date Report to Manufacturer11/23/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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