MAUDE Adverse Event Report: O&M HALYARD, INC. HALYARD U-BAR PACK VII; SURGICAL DRAPES AND PACKS

Model Number	77769
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in this complaint is said to be available for evaluation but has not been received.A follow-up report will be provided upon conclusion of the investigation.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
A 62-year-old patient was admitted for creation of a right-wrist radiocephalic arteriovenous fistula.During the procedure, foreign material was observed contaminating the sterile field, presenting a potential contamination risk.No patient harm was reported.
Additional Manufacturer Narrative
The sample was examined under ambient light conditions.A dark foreign material, measuring approximately 1.5 cm, was observed affixed to the adhesive.Under magnification, the foreign material resembled a crushed winged insect, with reddish stains around and near it.The portion that remained on the poly bag also showed fragments that could be described as a wing and several appendages.Observations indicate the apparent insect is on the outside of the adhesive and not between the adhesive and the drape material.The top side of the drape was unaffected.The device history record for the lot was reviewed and confirmed to meet all manufacturing and quality specifications, with no rework or special conditions reported.Pest control and fumigation plans are in place, including monthly perimeter and common area treatments, air curtains in production cells, and light traps around the dock to prevent insect intrusion.The fumigation program covers rodents, flying insects, birds, and other pests.Foreign materials and stains on pack 77769-80 show a downward trend, with this being the first incident reported between february 2024 and february 2026.Personnel in the cutting area were informed of the incident for awareness.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 U-BAR PACK VII
• Common Device Name: SURGICAL DRAPES AND PACKS
• Manufacturer (Section D): O&M HALYARD, INC.; 1220 old alpharetta rd; ste 320; alpharetta GA 30005
• Manufacturer (Section G): LA ADA DE ACUNA, S. DE. R. L. DE C. V.; av. hidalgo no. 6 esq; blvd. luis donaldo colosio; col.educativa, nogales sonora
• Manufacturer Contact: nichole coggins ; 1220 old alpharetta rd; ste 320; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 24401963
• Report Number: 3005997949-2026-00001
• Device Sequence Number: 8300192
• Product Code: LRO
• UDI-Device Identifier: 30680651777691
• UDI-Public: 30680651777691
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Physician
• 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: 77769
• Device Catalogue Number: 77769
• Device Lot Number: AC2513201A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/06/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 62 YR
• Patient Sex: Unknown