MAUDE Adverse Event Report: O&M HALYARD, INC. HALYARD SURGICAL CAP BLUE UNIVERSAL SIZE; PROTECTIVE APPAREL

Model Number	69520
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the event was not available for return.O&m halyard, inc.Is the specification developer and complaint handling establishment of the halyard surgical cap, blue, universal size.The complaint component halyard surgical cap, blue, universal size, part number 69520 is contract manufactured by jiehong medical products (b)(6) co.Ltd (fda registration number (b)(4)).A supplier corrective action (scar) was submitted to the manufacturer on (b)(6) 2026.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 a o&m halyard, inc.Product is defective or has caused serious injury.
Event or Problem Description
The current caps do not adequately absorb perspiration, allowing sweat to drip into the surgical wound, which presents a quality concern.Customer indicated the rooms are hot in the peds area which is where issue has been reported.Additional incident details were requested on (b)(6) 2026, (b)(6) 2026, and (b)(6) 2026; however, no responses have been received.
Additional Manufacturer Narrative
The complaint was referred to the supplier, (b)(6) for investigation and root cause analysis.The investigation confirmed that product code 69520 is made from a non-wettable material that does not absorb perspiration, as verified through product design review and sample testing.Since this material is unsuitable for hot environments where moisture absorption is needed, it is recommended that customers use product 69240, which is constructed from a wettable material specifically designed to absorb perspiration.No similar complaints have been reported previously, and no sample was returned for further evaluation.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 a o&m halyard, inc.Product is defective or has caused serious injury.

• Brand Name: HALYARD SURGICAL CAP BLUE UNIVERSAL SIZE
• Common Device Name: PROTECTIVE APPAREL
• Manufacturer (Section D): O&M HALYARD, INC.; 1220 old alpharetta rd; ste 320; alpharetta GA 30005
• Manufacturer (Section G): JIEHONG MEDICAL PRODUCTS(BANGLADESH) CO.LTD; fs-1 (2nd floor, both wings); road #2 (chattogram export processing zone); chattogram chittagong, bangladesh
• Manufacturer Contact: nichole coggins ; 1220 old alpharetta rd; ste 320; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 24235031
• Report Number: 3014421917-2026-00002
• Device Sequence Number: 10188086
• Product Code: FYF
• UDI-Device Identifier: 30680651695209
• UDI-Public: 30680651695209
• 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): 03/13/2026

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: 69520
• Device Catalogue Number: 69520
• Device Lot Number: UNKNOWN
• 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: 01/19/2026
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 03/13/2026
• 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