MAUDE Adverse Event Report: O&M HALYARD, INC. HALYARD THREE QUARTER DRAPE

Model Number	47629
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported foreign material in the fold of the 3/4" drape.The foreign debris contaminated sterile field, including prepped instruments.The issue was identified after the patient was draped but prior to incision.The or room had to be cleaned while patient was under anesthesia and a new sterile field created including new supplies and instruments.
Additional Manufacturer Narrative
The product involved in the event was not returned for evaluation.A follow-up report will be provided upon conclusion of investigation.This product incident is documented in the 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
Correction: drape lot number was updated to 12-7124011.The device history record for complaint lot was reviewed, the lot was found to meet all manufacturing and quality specifications prior to release.No rework was reported.Twelve months of complaint trending data was evaluated.There are other foreign material complaints logged; however, none of these indicate a similar metal foreign material.There is a hot gluing machine utilized during subassembly.The machine conditions were verified, and machine appeared to be optimally functional with no metal particles found.At this time, the complaint has been deemed isolated with no defined root cause.All assembly personnel were notified of incident for awareness.The site will continue to monitor for any subsequent complaints which would warrant corrective action.This product incident is documented in the 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.

• Brand Name: HALYARD THREE QUARTER DRAPE
• Common Device Name: HALYARD THREE QUARTER DRAPE
• 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; nogales sonora 84093 ; MX 84093
• Manufacturer Contact: nichole coggins ; 1220 old alpharetta rd; ste 320; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 20312067
• Report Number: 3005997949-2024-00009
• Device Sequence Number: 18363746
• Product Code: PUI
• UDI-Device Identifier: 20680651476290
• UDI-Public: 20680651476290
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): N
• 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): 02/17/2025

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: 47629
• Device Catalogue Number: 47629
• Device Lot Number: 12-7124011
• 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: 09/12/2024
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 02/18/2025
• 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