MAUDE Adverse Event Report: O&M HALYARD, INC. HALYARD; WRAP, STERILIZATION

Model Number	34147
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Flaking was discovered on the size labeling within the wrap.The technician placed a piece of tape over the labeling, and black flakes from the printing came off with the tape.

• Brand Name: HALYARD
• Common Device Name: WRAP, STERILIZATION
• Manufacturer (Section D): O&M HALYARD, INC.; 1220 old alpharetta rd ste 320; alpharetta GA 30005
• MDR Report Key: 24188013
• Report Number: 24188013
• Device Sequence Number: 21226243
• Product Code: FRG
• UDI-Device Identifier: 20680651341475
• UDI-Public: (01)20680651341475
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/13/2026
• Report Date (Section F): 01/13/2026

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
• Device Model Number: 34147
• Device Catalogue Number: 34147-02
• Device Lot Number: LT4310000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/27/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/13/2026