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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HALYARD HEALTH KC200 OS WRAP 48X48 STERILIZATION WRAP

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HALYARD HEALTH KC200 OS WRAP 48X48 STERILIZATION WRAP Back to Search Results
Model Number 62048
Device Problems Hole In Material (1293); Device Disinfection Or Sterilization Issue (2909)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/07/2016
Event Type  malfunction  
Manufacturer Narrative
Udi # unknown. (b)(4). The actual complaint product was not returned for evaluation. A review of the device history record is not possible as no lot number was provided. Root cause could not be determined. Unable to determine root cause. 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 there were holes in the sterilization wraps. Additional information has been requested.
 
Manufacturer Narrative
The actual sample was received without original packaging. The sample had strips of paper tape affixed on one side. Visual evaluation revealed that the sample has strips of paper tape affixed on one side. The customer has circled the areas of concern on the sample. There were multiple occurrences of small holes in the sterilization wrap. Each hole measured approximately 1mm in size. The holes penetrated both layers of nonwoven. The manufacturing process was reviewed, and it was determined that this type of hole can only happens after the two layers of fabric are bonded together. No root cause for the reported event could be 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).
 
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Brand NameKC200 OS WRAP 48X48
Type of DeviceSTERILIZATION 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 Key5741069
MDR Text Key47924877
Report Number1054380-2016-00007
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
PK082177
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 06/30/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/03/2020
Device Model Number62048
Device Catalogue Number991062048
Device Lot NumberLT5307000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/30/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/18/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/06/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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