MAUDE Adverse Event Report: HALYARD HEALTH QUICK CHECK* H500 STERILIZATION WRAP, 60IN. X 60IN. (152CM X 152CM); KIMGUARD ONESTEP STERILIZATION WRAP

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).

• Type of Device: KIMGUARD ONESTEP STERILIZATION WRAP
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7277965
• MDR Text Key: 100512776
• Report Number: 1054380-2018-00001
• Device Sequence Number: 1
• Product Code: FRG
• UDI-Device Identifier: 20680651341796
• UDI-Public: 20680651341796
• Combination Product (y/n): N
• PMA/PMN Number: K082177
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: 34179
• Device Catalogue Number: 991034179
• Device Lot Number: CO7189LTA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Date Manufacturer Received: 03/20/2018
• Patient Sequence Number: 1