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

Model Number	34159
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During an orthopedic procedure, a hole was reported in the product, resulting in a one-hour delay of the surgery.No patient injury was reported.
Additional Manufacturer Narrative
The sample is said to be available for evaluation but has not been received yet.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 an o&m halyard, inc.Product is defective or has caused serious injury.
Additional Manufacturer Narrative
One sample was received.The circled area indicated the presence of a hole measuring approximately 3 mm in diameter.The hole extends through both the white and blue layers, with alignment observed between the two.No additional tears, cuts, or holes were observed.A review of the device history record dated (b)(6) 2025, confirmed that process round checks for fabric defects were completed with no issues documented.All quality attribute visual inspections were recorded as passing, and no material was placed on hold or scrapped due to holes or cuts.Based on quality records, the material met all established specification requirements.Based on the evaluation of the defect, review of quality data, and assessment of the manufacturing process, the observed condition is not attributed to manufacturing.The product is constructed by bonding two separate sheets of material (blue and white), which are produced on different days.Therefore, it is highly unlikely that both layers would exhibit a precisely aligned hole originating during production.Manufacturing processes and product testing are closely monitored, and performance is evaluated through metrics such as complaints per million (cpm) and trend analysis.This event will be incorporated into the complaint review board¿s ongoing analysis to identify potential trends.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.

• Brand Name: KIMGUARD ONE-STEP QUICK CHECK STERILIZATION WRAP
• Common Device Name: STERILIZATION 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: 24428293
• Report Number: 1054380-2026-00004
• Device Sequence Number: 9905391
• Product Code: FRG
• UDI-Device Identifier: 30680651341595
• UDI-Public: 30680651341595
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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: 34159
• Device Catalogue Number: 34159
• Device Lot Number: LR5192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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