MAUDE Adverse Event Report: O&M Halyard, Inc KIMGUARD ONE-STEP QUICK CHECK STERILIZATION WRAP KC 600; Sterilization products

Model Number	34142
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction

• Brand Name: KIMGUARD ONE-STEP QUICK CHECK STERILIZATION WRAP KC 600
• 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 fritzgerald rd; linwood 27299
• Manufacturer Contact: angela bunn ; 1220 old alpharetta rd; ste 320; alpharetta, GA 30005 ; +1(770)401-1697
• MDR Report Key: 50105488
• Report Number: 1054380-2026-00010
• Device Sequence Number: 10032492
• Product Code: FRG
• UDI-Device Identifier: 20680651341420
• UDI-Public: 20680651341420
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 07/31/2026

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: 34142
• Device Catalogue Number: 34142
• Device Lot Number: LT6133
• 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: 07/01/2026
• Initial Report FDA Received Date: 07/31/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown