• 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 QUICK CHECK* H500 STERILIZATION WRAP, 60IN. X 60IN. (152CM X 152CM) 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 QUICK CHECK* H500 STERILIZATION WRAP, 60IN. X 60IN. (152CM X 152CM) KIMGUARD ONESTEP STERILIZATION WRAP Back to Search Results
Model Number 34179
Device Problem Hole In Material (1293)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/25/2018
Event Type  malfunction  
Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation. A review of the device history record is in-progress; a follow-up report will be filed. All information reasonably known as of (b)(6) 2018 has been included in this health authority report. Should additional information be obtained, a follow-up health authority report will be provided. The information provided by halyard health represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health. 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 there was a hole in the material that appeared to look like it was cut with a knife. The user is unsure if there might have been a hole in the material before shipping. It was found after use. No additional information was provided.
 
Manufacturer Narrative
One used sample was received with no product packaging. The sample has sterilization indicator tape affixed to the outside of the blue layer. The sample was laid out on the lab table for evaluation under ambient light conditions. The sample arrived with a circled area in black ink. The circled area exhibits what appears as a clean edged hole. The hole measures approximately 5mm in length which penetrates both the blue and white layers. The holes align on the layers. The area was examined under magnification. The orientation of the fibers and material around the edges indicates the hole was possibly formed from the blue side. The white side exhibits a few blue fibers near the hole. Based on pictures and the sample evaluation, the types of holes/cuts/puncture observed could not happen in the manufacturing process. A device history record evaluation will be conducted. A root cause could not be determined as occurring during manufacturing. All information reasonably known as of 29mar2018 has been included in this health authority report. Should additional information be obtained, a follow-up health authority report will be provided. The information provided by halyard health represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health. 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).
 
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
MDR Report Key7277965
MDR Text Key100512776
Report Number1054380-2018-00001
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
PMA/PMN Number
K082177
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other Health Care Professional
Device Model Number34179
Device Catalogue Number991034179
Device Lot NumberCO7189LTA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/12/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/20/2018
Is This a Reprocessed and Reused Single-Use Device?

-
-