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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HALYARD HEALTH KIMGUARD ONE-STEP* QUICK CHECK* STERILIZATION WRAP, KC 500, 45IN X 45IN KIMGUARD ONESTEP STERILIZATION WRAP

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HALYARD HEALTH KIMGUARD ONE-STEP* QUICK CHECK* STERILIZATION WRAP, KC 500, 45IN X 45IN KIMGUARD ONESTEP STERILIZATION WRAP Back to Search Results
Model Number 34198
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/21/2016
Event Type  malfunction  
Manufacturer Narrative
The initial report was submitted using the (b)(4). This report is being submitted as a correction to the initial report. This report is being submitted using the 7 digit cfn number, 1054380-2016-00001. Udi # unknown. (b)(4). One (1) unused sample was received with the sterilization tape on the blue side of the wrap. A hand-held camera and microscope was used to capture the defects. The sample received exhibited a defect. The defect was a small jagged slit located on the lower left side of the wrap when looking on the white side. The slit penetrated through both layers. The blue layer showed deformation of the daisy patterns on the wrap. It was located on the upper left quadrant of the wrap. The device history record for the lot number lr5055 , involved in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements. Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred. (b)(4).
 
Event Description
It was reported that the "customer found a small hole in wrap when the wrap was unwrapped in the operating room. There was no patient contact with the instruments that were wrapped, and no contamination with blood or bodily fluid. " no additional information provided.
 
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Type of DeviceKIMGUARD ONESTEP STERILIZATION WRAP
Manufacturer (Section D)
HALYARD HEALTH
5405 windward parkway
alpharetta GA 30004
Manufacturer (Section G)
HALYARD NORTH CAROLINA, INC.
389 clyde fitzgerald road
linwood NC 27299
Manufacturer Contact
lisa clark
5405 windward parkway
alpharetta, GA 30004
4704485444
MDR Report Key5660603
MDR Text Key46579912
Report Number1054380-2016-00001
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK082177
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/21/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/17/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other Health Care Professional
Device Expiration Date02/24/2020
Device Model Number34198
Device Catalogue Number991034198
Device Lot NumberLR5055
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/29/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/21/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/24/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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