MAUDE Adverse Event Report: O&M HALYARD, INC. KIMGUARD ONE-STEP* QUICK CHECK* STERILIZATION WRAP; SURGICAL PRODUCTS

Model Number	34164
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Incident two the sample is reported to be available but has not been returned.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 comp (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 an o&m halyard, inc.Product is defective or has caused serious injury.
Event or Problem Description
The customer reported rust staining on wrap where the tray was sitting.Additional information reported on april 15, 2025, states, there were a couple of procedure cancellations.
Additional Manufacturer Narrative
Incident two.One used sample was received.A large rectangular stain is outlined in the middle of the wrap where an instrument tray may have rested.The stain penetrated both blue and white layers in a corresponding outline.Manufacturing site reviewed the device history record for complaint lot.Site reviewed production records for fabric defects, and no issues had been documented.All quality attribute visual checks were documented as pass on these rolls.No material had been placed on hold or scrapped for material defects or stains.According to the quality records, this material met specification guidelines.Customer feedback is reviewed by the complaint review board which utilizes metrics such as cpm (complaints per million) and trend analysis to monitor the effectiveness of the process and quality control.Currently there are 1.4 complaints per million for this product, this does not warrant further actions.No further action will be taken at this time.A root cause was not identified.The stains were indicative of some type of reaction with the instrument tray the end-user was sterilizing.The sterilization materials and process utilized by the customer is unknown.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 21 cfr 803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an o&m halyard, inc.Product is defective or has caused serious injury.

• Common Device Name: SURGICAL PRODUCTS
• Manufacturer (Section D): O&M HALYARD, INC.; 1220 old alpharetta rd; ste 320; alpharetta GA 30005
• Manufacturer (Section G): HALYARD NORTH CAROLINA, LLC; 389 clyde fitzgerald rd; linwood NC 27299
• Manufacturer Contact: nichole coggins ; 1220 old alpharetta rd; ste 320; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 21911174
• Report Number: 1054380-2025-00003
• Device Sequence Number: 9042683
• Product Code: FRG
• UDI-Device Identifier: 30680651341649
• UDI-Public: 30680651341649
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K234050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 06/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 34164
• Device Catalogue Number: 991034164
• Device Lot Number: LT4306
• Was Device Available for Evaluation?: Yes
• 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: 03/26/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown