MAUDE Adverse Event Report: O&M HALYARD, INC. KIMGUARD ONESTEP* QUICK CHECK* STERILIZATION WRAP, KC 600, 45IN X 45IN; HALYARD* QUICK CHECK* STERILIZATION WRAP

Model Number	34164
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the event was not available for return.A follow-up report will be provided upon conclusion of investigation.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a o&m halyard, inc.Product is defective or has caused serious injury.Device not returned.
Event or Problem Description
Incident one.Customer reported they have experienced wet packs.This resulted in patient delay in procedure.Additional incident details have been requested.
Additional Manufacturer Narrative
The product involved in the event was not available for return.According to the customer, these wet packs were found post-sterilization.With the incident occurring post-sterilization, it's unclear what contributing factors the end-user utilized when further processing the wrap which may have contributed to the product issue.Customer complaints are reviewed monthly during complaint review board which utilizes metrics including cpm(complaint per million) and trend analysis to monitor the effectiveness of process and quality control.Given there was no lot number provided, the site is unable to review the device history records to determine if there was any issue that occurred during manufacture that may contribute.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a o&m halyard, inc.Product is defective or has caused serious injury.H3 other text : device not returned.

• Common Device Name: HALYARD* QUICK CHECK* STERILIZATION WRAP
• Manufacturer (Section D): O&M HALYARD, INC.; 1 edison drive; alpharetta GA 30005
• Manufacturer (Section G): HALYARD NORTH CAROLINA, LLC; 389 clyde fitzgerald road; linwood NC 27299
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 16989423
• Report Number: 1054380-2023-00001
• Device Sequence Number: 6343758
• Product Code: FRG
• UDI-Device Identifier: 30680651341649
• UDI-Public: 30680651341649
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K214007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 34164
• Device Catalogue Number: 991034164
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2023
• Supplement Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown