MAUDE Adverse Event Report: O&M HALYARD, INC. HALYARD SET-UP PACK I; SURGICAL DRAPES AND PACKS

Model Number	88171
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A long strand of hair was discovered inside the package, embedded within the large tablecloth.As a precaution, all items that had come into contact with the tablecloth were discarded.This incident resulted in a 30-minute prolonged procedure time for patient.Patient otherwise had no adverse effects.
Additional Manufacturer Narrative
The product involved in this complaint is not available for evaluation.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 product is defective or has caused serious injury.
Additional Manufacturer Narrative
Sample pictures were provided, and the incident has been confirmed.A review of the device history record (dhr) for the specified lot confirmed that all manufacturing processes and quality specifications were met prior to product release.The lot was in full compliance with applicable process requirements, and no instances of rework or special conditions were documented.No trend of foreign material or stains has been observed for this product.The potential root cause of this defect was identified as the improper use of hair nets and ninja-style hoods by personnel working on the line or by those involved in preceding processes that feed the line.Personnel on the affected manufacturing line were notified of the incident, and sample pictures were shared to raise awareness of the issue and emphasize the importance of delivering contamination-free materials.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint comp-(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 product is defective or has caused serious injury.

• Brand Name: HALYARD SET-UP PACK I
• 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: 23325193
• Report Number: 3005997949-2025-00009
• Device Sequence Number: 18626310
• Product Code: KKX
• UDI-Device Identifier: 30680651881718
• UDI-Public: 30680651881718
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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: 88171
• Device Catalogue Number: 88171
• Device Lot Number: AC2510305D
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 10/28/2025
• 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