MAUDE Adverse Event Report: O&M HALYARD, INC. KIMGUARD ONE-STEP QUICK CHECK STERILIZATION WRAP, KC 500; STERILIZATION PRODUCTS

Model Number	34148
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is available for evaluation.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.
Event or Problem Description
Customer stated that while wrapping a tray for sterilization, she found metal shavings in the sterilization wrap.A metal shaving poked her and broke the skin on her finger.The customer was not able to locate the metal shaving for evaluation.A secondary issue for sterilization wrap was communicated, the daisy pattern was raised and there was linting observed.This caused a two-hour delay.No cases were canceled.The customer stated they resolved the issue by opening new trays.
Additional Manufacturer Narrative
A sample or photo was not available for evaluation.The complaint device history record (dhr) was reviewed, no issues were documented.All quality visual checks were documented as "pass".No product was placed on hold for foreign material or metal shavings.According to quality records, this material met specification guidelines.A root cause could not be determined.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.This incident has been communicated to the manufacturing teams and will be included in our trend analysis to monitor for any corrective action needs.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.

• Brand Name: KIMGUARD ONE-STEP QUICK CHECK STERILIZATION WRAP, KC 500
• 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: 21548112
• Report Number: 1054380-2025-00001
• Device Sequence Number: 15462717
• Product Code: FRG
• UDI-Device Identifier: 30680651341489
• UDI-Public: 30680651341489
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 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): 04/21/2025

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: 34148
• Device Catalogue Number: 34148
• Device Lot Number: LT4280
• 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: 02/25/2025
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 04/21/2025
• 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