MAUDE Adverse Event Report: O&M HALYARD, INC. SURGICAL EENT IV PACK 5; SURGICAL DRAPES AND PACKS

Model Number	88719
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 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 a o&m halyard, inc.Product is defective or has caused serious injury.
Event or Problem Description
During the placement of the head sheet, the surgeon realized the sheet was covered with dust, compromising sterility.There was a 20-minute delay to the start of surgery.New asepsis and antisepsis protocols were performed to prevent contamination in the surgery room to protect the patient's health.
Additional Manufacturer Narrative
This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint (b)(4).An investigation was performed that included a review of sample pictures and the device history record (dhr).The pictures revealed embedded dirt on the drape.No abnormalities were found in the dhr, the lot met all manufacturing process and quality specifications for release.There was no rework conducted during lot manufacture.Process review did not identify any sources of dust particles during manufacturing.Cleaning and sanitization procedures were verified, confirming that surfaces are cleaned at the start of each shift and floors are cleaned daily or as needed.The manufacturing line was notified of complaint for awareness.Site will continue to track and trend complaints to determine if corrective actions are warranted.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: SURGICAL EENT IV PACK 5
• 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 84093 ; MX 84093
• Manufacturer Contact: nichole coggins ; 1220 old alpharetta rd; ste 320; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 21218853
• Report Number: 3005997949-2025-00001
• Device Sequence Number: 8640280
• Product Code: PUI
• UDI-Device Identifier: 30680651887192
• UDI-Public: 30680651887192
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K083234
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2025

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: 88719
• Device Catalogue Number: 88719
• Device Lot Number: AC2418703D
• 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: 01/13/2025
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 02/26/2025
• 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