• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HALYARD HEALTH KC400 OS WRAP 40X40 STERILIZATION WRAP KIMGUARD

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

HALYARD HEALTH KC400 OS WRAP 40X40 STERILIZATION WRAP KIMGUARD Back to Search Results
Model Number 62240
Device Problem Cut In Material (2454)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). One unused sample which was not returned with the original packaging was received. The sterilization wrap was opened across the table in order to view the product in its entirety. After examining the quadrants of the wrap, the sample appeared to have a slit in the fabric. The slit is located in the middle section, top portion of the device (front layer) and penetrated through the (back layer) of the wrap. The device history record for lr5225 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 1054380-2016-00005.
 
Event Description
It was reported that there was a hole found in the wrap through 2 layers. No additional information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameKC400 OS WRAP 40X40
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 rd 
linwood NC 27299
Manufacturer Contact
lisa clark
5405 windward parkway
alpharetta, GA 30004
4704485444
MDR Report Key5686392
MDR Text Key46200019
Report Number1054380-2016-00005
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
Reporter Country CodeFR
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
Report Date 05/18/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/27/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number62240
Device Catalogue Number991062240
Device Lot NumberLR5225
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/23/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/13/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

-
-