MAUDE Adverse Event Report: O&M HALYARD, INC. HALYARD IMPERVIOUS STOCKINETTE LARGE 12 IN 48 IN; SURGICAL DRAPES AND PACKS

Model Number	89821
Medical Device Problem Code	Material Separation (1562)
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 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
The stockinette was reported to have torn during the surgical procedure.Additional information has been requested regarding incident and impact on patient; however, no response has been received at this time.
Additional Manufacturer Narrative
The device history record and qnc (quality nonconformance) databases were reviewed and confirmed that all manufacturing processes and quality specifications were met prior to product release.No rework or special conditions were identified.This investigation was conducted based on the information provided by the customer, which included a single photograph of the sample.In response to the reported issue of open seals on stockinettes, an internal investigation was performed to identify any abnormalities or contributing factors within our processes.Handling at the la ada de acuna, s.De.R.L.De c.V.Site consists only of wrapping the product with csr wrap and packaging it using form, fill, and seal (ffs) equipment.The manufacture of the stockinettes is performed entirely by tex-care.A supplier corrective action request (scar) was initiated on june 9, 2025, and completed on august 11, 2025.The supplier determined that the root cause of the open-seal issue was an inadequate or inconsistent sealing process at the foot-end during manufacturing.The supplier corrective actions were implemented beginning with lot ac2534402c manufactured on 12/10/25.The manufacturing date for complaint lot was 02/27/25 (prior to implementation of corrective actions).Corrective actions include seal strength and integrity testing at critical points (including foot-end), and updated inspection protocol.Trending analysis indicates no current trend for similar issue for product since implementation of corrective actions.To further mitigate recurrence, packaging personnel were notified of the issue to reinforce awareness and emphasize the importance of delivering defect-free products.This product incident is documented in the o&m halyard, inc.Complaint database and identified as (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 IMPERVIOUS STOCKINETTE LARGE 12 IN 48 IN
• 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: 24517876
• Report Number: 3005997949-2026-00003
• Device Sequence Number: 8514629
• Product Code: PUI
• UDI-Device Identifier: 30680651898211
• UDI-Public: 30680651898211
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 04/20/2026

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: 89821
• Device Catalogue Number: 89821
• Device Lot Number: AC2505801E
• 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: 02/20/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 04/20/2026
• 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