• 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 KIMGUARD ONE-STEP* QUICK CHECK* STERILIZATION WRAP% KC 600% 54IN X 54IN KIMGUARD ONESTEP STERILIZATION WRAP

  • 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 KIMGUARD ONE-STEP* QUICK CHECK* STERILIZATION WRAP% KC 600% 54IN X 54IN KIMGUARD ONESTEP STERILIZATION WRAP Back to Search Results
Model Number 34142
Device Problem Hole In Material (1293)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(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. 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). Device not returned.
 
Event Description
Halyard received a single report that referenced five different incidences, which were associated with separate units. This is the second of five reports. Refer to 1054380-2016-00008 for the first report. Refer to 1054380-2016-00010 for the third report. Refer to 1054380-2016-00011 for the fourth report. Refer to 1054380-2016-00012 for the fifth report. It was reported that there were pinholes experienced five times during post-sterilization. The incidents was discovered in sterile processing and the instruments did not reach the operating room, and no patients were involved. No additional information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 rd
linwood NC 27299
Manufacturer Contact
lisa clark
5405 windward parkway
alpharetta, GA 30004
4704485444
MDR Report Key5763197
MDR Text Key49069667
Report Number1054380-2016-00009
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 06/22/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/30/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other Health Care Professional
Device Model Number34142
Device Catalogue Number991034142
Device Lot NumberUNKNOWN
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

-
-