MAUDE Adverse Event Report: O&M HALYARD, INC. HALYARD ARMBOARD COVER 14 IN. - 31.5 IN; SURGICAL ACCESSORIES

Model Number	44591
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 event is not available for evaluation.O&m halyard, inc.Is the specification developer and complaint handling establishment of the complaint product (b)(4).The product is contract manufactured by principle & will biotech (pinghu) co., ltd.(fda registration number 3006973666).A scar was issued to the contract manufacturer on november 25, 2024.A follow-up report will be provided upon conclusion of 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 an o&m halyard, inc.Product is defective or has caused serious injury.
Event or Problem Description
The adhesive edge was so weak that it opened after applying them to the surgeon's operation chair.This incident caused a breach in sterility during cataract procedure.Distributor reported there was no injury associated, nor medical treatment required.Distributor reported complaint but failed to provide end-user information to obtain additional patient outcome information.
Additional Manufacturer Narrative
Based on the investigation, the root cause is identified as incorrect gluing (insufficient glue application) completed by operator.The manufacturer reviewed training records for personnel who performed the adhesive application for complaint lot.All personnel had passed assessments prior to performing this work.The manufacturer performed a trending review, finding 0.34 complaints per million were received for this issue.There was no negative trend for the defect observed.The following actions were taken.The adhesive application process was revised to include a smoothing action after adhesive application, ensuring proper bonding.Personnel of the involved manufacturing line were notified of incident to raise awareness.The manufacturer has implemented a mentorship approach to training for all personnel who are new or transitioning to adhesive application.Line leaders will enhance inspections when new personnel are performing process.Manufacturer will provide refresher training to quality inspectors on inspection processes to detect adhesive failures.Manufacturer revised inspection specification and testing requirements for tensile force to increase detection.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 an o&m halyard, inc.Product is defective or has caused serious injury.

• Brand Name: HALYARD ARMBOARD COVER 14 IN. - 31.5 IN
• Common Device Name: SURGICAL ACCESSORIES
• Manufacturer (Section D): O&M HALYARD, INC.; 1220 old alpharetta rd; ste 320; alpharetta GA 30005
• Manufacturer (Section G): PRINCIPLE & WILL BIOTECH (PINGHU) CO., LTD.; no. 2000 xing ping 2nd road; economic development zone; pinghu city zhejiang, cn ; CH
• Manufacturer Contact: nichole coggins ; 1220 old alpharetta rd; ste 320; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 20988911
• Report Number: 3014421917-2024-00021
• Device Sequence Number: 15566793
• Product Code: PUI
• UDI-Device Identifier: 30680651445910
• UDI-Public: 30680651445910
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2025

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: 44591
• Device Catalogue Number: 44591
• Device Lot Number: JK23293069
• 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: 11/22/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 12/20/2024
• Supplement Report FDA Received Date: 01/29/2025
• 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