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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: O&M HALYARD INC. QUICK CHECK STERILIZATION WRAP WRAP, STERILIZATION

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O&M HALYARD INC. QUICK CHECK STERILIZATION WRAP WRAP, STERILIZATION Back to Search Results
Catalog Number 34198
Device Problem Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/17/2020
Event Type  malfunction  
Event Description
(b)(4): wrap has multiple holes in it in a linear line with packaging intact. Defect is from manufacturer. This week, there have been trays with holes in the wrap that match this pattern of holes.
 
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Brand NameQUICK CHECK STERILIZATION WRAP
Type of DeviceWRAP, STERILIZATION
Manufacturer (Section D)
O&M HALYARD INC.
9120 lockwood blvd
mechanicsville VA 23116
MDR Report Key11162944
MDR Text Key226620434
Report Number11162944
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number34198
Device Lot NumberLR0292000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/04/2021
Event Location Hospital
Date Report to Manufacturer01/13/2021
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 Unkown

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