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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HALYARD HEALTH KC600 OS WRAP 40X40 STERILE WRAP KIMGUARD ONE STEP

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HALYARD HEALTH KC600 OS WRAP 40X40 STERILE WRAP KIMGUARD ONE STEP Back to Search Results
Model Number 62640
Device Problem Hole In Material (1293)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/16/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The actual complaint product was returned for evaluation. One used sample was received with no packaging. The sample has sterilization indicator tape affixed on one side. The sample has a small hole with penetrates both layers of the wrap. The hole is directly aligned with visible tray compression marks on the material. The sample also exhibits an area of abrasion. This has not created a hole in the material. This event occurred post sterilization. The device history record for the lot number, lt5336, involved in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements. Root cause was not determined. 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. This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).
 
Event Description
It was reported that the customer that there was a hole through both layers of the wrap found post sterilization. There was no patient involvement. No additional information received.
 
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Brand NameKC600 OS WRAP 40X40
Type of DeviceSTERILE WRAP KIMGUARD ONE STEP
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 Key5775016
MDR Text Key49069865
Report Number1054380-2016-00013
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 06/16/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other Health Care Professional
Device Expiration Date12/02/2020
Device Model Number62640
Device Catalogue Number991062640
Device Lot NumberLT5336
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/01/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/16/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/03/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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