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

Model Number	34183
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One used sample was received for evaluation.The sample was received with a circled area identifying the reported defect location, which appeared to be a clean-edged slit.The slit penetrated both layers and aligned across each layer.Based on tracking and trending data, the moving average for this defect issue is approximately 0.9 cpm (complaints per million), with no negative trend identified over the past 12 months.A root cause for this specific incident could not be determined within our manufacturing process.The sample was received in a post-sterilized condition, and details regarding the sterilization process and associated conditions were not available for evaluation.Manufacturing process controls and product testing results are routinely monitored and used to support continuous quality improvement activities.Customer feedback is reviewed by the complaint review board, which utilizes metrics such as cpm (complaints per million) and statistical trend analysis to evaluate process effectiveness and quality performance.This incident will be incorporated into ongoing complaint trending and review activities to support identification of any emerging patterns.No additional corrective actions are required at this time, a review of the device history record confirmed that the material met established specification requirements.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.
Event or Problem Description
The customer reported that holes were identified in the product after sterilization in the operating room, resulting in a delay of the procedure.The surgery was not canceled; however, a breach of the sterile barrier was noted.Information was received on march 31, 2026, stating there was hole in the wrap discovered when opening the box.A questionnaire was sent to the reporter who replied on (b)(6) 2026 with further details indicating this was discovered in the operating room and there was a breach in sterility at which point the new details led to conclusion this was a reportable malfunction due to increased likelihood that recurrence may lead to a serious injury or illness.

• Brand Name: KIMGUARD ONE-STEP QUICK CHECK STERILIZATION WRAP
• Common Device Name: STERILIZATIONS 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: 25304217
• Report Number: 1054380-2026-00005
• Device Sequence Number: 13103406
• Product Code: FRG
• UDI-Device Identifier: 30680651341830
• UDI-Public: 30680651341830
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K234050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2026

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: 34183
• Device Catalogue Number: 991034183
• Device Lot Number: LR5078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2026
• 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: 03/31/2026
• Initial Report FDA Received Date: 05/27/2026
• 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