MAUDE Adverse Event Report: O&M HALYARD, INC. HALYARD HI GUARD ULTRA FULL COVERAGE BOOT UNIVERSAL; PROTECTIVE APPAREL

Model Number	69572
Medical Device Problem Code	Device Unsafe to Use in Environment (2918)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the event is not available for evaluation.O&m halyard, inc.Is the specification developer and complaint handling establishment of the halyard hi guard ultra full coverage boot, universal.The complaint component halyard hi guard ultra full coverage boot, universal, part number: 69572 is contract manufactured by hubei xinxin non-woven co., ltd (fda registration number: 3011547453).Supplier corrective action request (scar) was submitted to the manufacturer on december 22, 2025.A follow-up report will be provided upon conclusion of investigation and response by the manufacturer.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
Sterile processing reported the foam strips on the bottom of the boot covers are detaching and occasionally creating a tripping hazard in the decontamination area.No injuries or medical treatment was reported by user.
Additional Manufacturer Narrative
According to the device history record, lot hx25216884 was manufactured and completed without any deviations, and no similar issues were identified during final inspection.A retained sample from the complaint batch, consisting of one boot cover, was evaluated and no issues were observed with the black foam strips detaching.Two similar complaints related to product 69572 were received within the past 12 months; however, no adverse trends were identified.Actions taken by the supplier included defining a clear isolation length, implementing verification using a meter counter, and strengthening in-process inspection and documentation.Hubei xinxin (contract manufacturer) has indicated problem likely originated from foam supplier.Hubei xinxin has implemented a clear isolation length of material before and after to establish a buffer zone.Verification via meter counter has been implemented to accurately measure and confirm product length.In-process quality control will verify the length during inspections.Increased sample inspections are being performed per batch.Complaint photos have been posted at manufacturing workshop.Production personnel were informed of the issue and instructed to closely monitor for any separation between the adhesive and foam strip during routine operations.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: HALYARD HI GUARD ULTRA FULL COVERAGE BOOT UNIVERSAL
• Common Device Name: PROTECTIVE APPAREL
• Manufacturer (Section D): O&M HALYARD, INC.; 1220 old alpharetta rd.; ste 320; alpharetta GA 30005
• Manufacturer (Section G): HUBEI XINXIN NON-WOVEN CO., LTD; taizihu industrial park; pengchang town xiantao; hubei, 433018
• Manufacturer Contact: nichole coggins ; 1220 old alpharetta rd; ste 320; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 24083311
• Report Number: 3014421917-2026-00001
• Device Sequence Number: 14946359
• Product Code: FXP
• UDI-Device Identifier: 30680651695728
• UDI-Public: 30680651695728
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 02/12/2026

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: 69572
• Device Catalogue Number: 69572
• Device Lot Number: HX25216884
• 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: 12/18/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 02/12/2026
• 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