MAUDE Adverse Event Report: O&M HALYARD, INC. HALYARD CARDIOVASCULAR PACK II; SURGICAL DRAPES AND PACKS

Model Number	77748
Medical Device Problem Codes	Misconnection (1399); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during a surgical procedure using a cardiovascular pack, the bag of the incise sheet tore off and medical instruments fell to the floor.The customer believes this was an issue with the adhesion of the pockets.The customer attached the bag using other devices.This occurred during a cardiovascular procedure.There was a 30-minute surgical delay in procedure.
Additional Manufacturer Narrative
The current inventory of the complaint drape was checked and a retained sample was tested to evaluate the adhesive performance under simulated conditions.The hot melt adhesive patterns were inspected and found to be properly placed, continuous, and strong enough to adhere the pockets and drape.A weight of approximately 3.3 lb.Was placed inside each pocket to simulate normal use.After one hour, there was minor detachment observed in small areas of both pockets; however, the pockets remained functional and continued holding the weights.After seven hours, the right pocket showed two additional openings in the adhesive pattern.The left pocket showed one small and one larger opening.Despite this, the weights were still being held in place.The device history record was reviewed for the complaint lots manufactured.The documentation indicates the lot met all manufacturing and product specifications required prior to release.No rework or special conditions were reported.Prolonged testing showed some gradual adhesive loosening over time, though it did not result in functional failure.An internal nonconformance record (qnc-no3-25-00116) was created to determine if any corrective actions should be taken based on test results.There is no trend for detachment issues on drapes for at least 10 years, this is the first time this incident has been reported in that period.Notification of this incident was sent to manufacturing personnel.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 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 CARDIOVASCULAR PACK II
• 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: 21878257
• Report Number: 3005997949-2025-00004
• Device Sequence Number: 12729072
• Product Code: PUI
• UDI-Device Identifier: 30680651777486
• UDI-Public: 30680651777486
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• PMA/510(K) Number: K862801
• 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): 06/11/2025

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: 77748
• Device Catalogue Number: 77748
• Device Lot Number: AC241900A, AC2428104A
• 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: 04/04/2025
• Supplement Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 06/11/2025
• 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