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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HALYARD HEALTH KC100 WRAP 30X30 STERILIZATION WRAP KIMGUARD

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HALYARD HEALTH KC100 WRAP 30X30 STERILIZATION WRAP KIMGUARD Back to Search Results
Model Number 10730
Device Problem Cut In Material (2454)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Five unused lot samples were returned for evaluation. Visual examination revealed that there were slits found in all, around the center of the wraps. All the slits exhibited a very fine edge with no jaggedness. Additional investigation into root cause is in progress. A follow up report will be filed. The device history record for ln5157 was reviewed and the product was produced according to product specifications. 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 uses the wraps to sterilize bowls. While unwrapping the bowls in the o. R. , the nurse noticed long cuts in the wrap. No further information has been provided.
 
Manufacturer Narrative
No root cause for the reported event could be identified. Tear/cut/holes made in converting or base fabric manufacturing are not consistent with the shape/size identified in the evaluation. As a result, a manufacturing related cause has been ruled out. The cuts found on the fabric are consistent with the kind made by a knife. 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).
 
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Brand NameKC100 WRAP 30X30
Type of DeviceSTERILIZATION WRAP KIMGUARD
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 Key5778806
MDR Text Key49071080
Report Number1054380-2016-00014
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK082554
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/19/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/08/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/06/2020
Device Model Number10730
Device Catalogue Number991010730
Device Lot NumberLN5157
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/27/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/19/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/07/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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