MAUDE Adverse Event Report: O&M Halyard, Inc. KIMGUARD ONE-STEP QUICK CHECK STERILIZATION WRAP KC 500 36IN; Sterilization Products

Model Number	34199
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 500 36IN
• 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: angela bunn ; 1220 old alpharetta rd; ste 320; alpharetta, GA 30005 ; +1(770)401-1697
• MDR Report Key: 50261013
• Report Number: 1054380-2026-00011
• Device Sequence Number: 10672576
• Product Code: FRG
• UDI-Device Identifier: 20680651341994
• UDI-Public: 20680651341994
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/13/2026

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: 34199
• Device Catalogue Number: 34199
• Device Lot Number: LR6084000
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/28/2026
• 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: 07/15/2026
• Initial Report FDA Received Date: 08/14/2026
• 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