MAUDE Adverse Event Report: O&M HALYARD, INC. AERO BLUE PERFORMANCE SURGICAL GOWN WITH TOWEL X-LONG, XXL

Model Number	43938
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
An incident occurred during surgery where part of the imprinted logo of the "halyard" symbol on the surgical gown fell off and landed into the patients open wound during surgery.Additional information was requested on june 3, 2024, june 6, 2024, and june 10, 2024, but no further information has been received.
Additional Manufacturer Narrative
Two samples were received and evaluated.The cut-out section of the gown with the halyard logo was evaluated first.The section of the gown received measures approximately 3 x 6 inches.The bottom section of the letter "h" on the logo is missing.The edge of the remaining ink of the missing letter appears jagged.The letter "h" and the letter "a" were viewed under magnification.A magnification photo of the letter "a" was taken from a side view.The bottom of the letter appears that it is peeling off of the gown material.The sealed unused gown was evaluated next.There are no visual anomalies observed on the package.The package was opened, and the gown sample inside the csr wrap was unfolded.The sample was laid out on the lab table with the front of the gown facing up.There are no visual anomalies observed on the front of the gown.The back and inside of the gown were inspected.There is an incomplete sewn edge on the left raglan seam.The incomplete sewing does not indicate a gap in the seam but rather the outer sewn area of the seam is missing a few stitches.Next, the halyard logo was inspected.The ink of the letters on the logo appears securely printed.The logo letters were gently manipulated by hand.There was no detachment of ink or detachment of any of the letters.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 and should not be considered to be an admission that an o&m halyard, inc.Product is defective or has caused serious injury.
Additional Manufacturer Narrative
Two samples were received and evaluated.On sample one, the bottom section of the letter "h" on the logo is missing.The edge of the remaining ink of the missing letter appears jagged.The bottom of the letter "a" appears that it is peeling off of the gown material.Sample two, sealed unused gown was evaluated.The logo was inspected.The ink of the letters on the logo appears securely printed.The logo letters were gently manipulated by hand.There was no detachment of ink or detachment of any of the letters.A device history record review was performed for complaint lot ah4104tqh.The set-up parameters of the machine in charge of the hyh logo application was reviewed at the beginning of the shift to confirm that machine was operating within the validated parameters.The logo application is semi-manual, it consists of stamping logo by heat transfer on machine that is operated by machine operator in manufacturing line.The operator must place one piece of fabric under the piston and press the activation pedal to stamp logo on fabric; after stamping logo, the fabric is removed from station and the next piece is positioned.This operation is performed one piece of fabric at a time.The operator performs a visual verification of logo for each fabric piece.Machine annual calibration was performed with all results within specification.Preventive maintenance is performed every 13 weeks per procedure, the maintenance was performed and completed february 11, 2024.Gowns were evaluated onsite and 100% of the product inspected, was found to have halyard logo meeting acceptance criteria.No stamping defects or letter detachment was observed during inspection.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: AERO BLUE PERFORMANCE SURGICAL GOWN WITH TOWEL X-LONG, XXL
• Common Device Name: SURGICAL GOWN
• Manufacturer (Section D): O&M HALYARD, INC.; 1 edison drive; alpharetta GA 30005
• Manufacturer (Section G): O&M HALYARD HONDURAS S.A DE C.; carretera tegucigalpa; villaneva cortes, hn ; HO
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 19615336
• Report Number: 9680646-2024-00006
• Device Sequence Number: 14957020
• Product Code: FYA
• UDI-Device Identifier: 30680651439384
• UDI-Public: 30680651439384
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K192362
• 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): 07/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 43938
• Device Catalogue Number: 104393801
• Device Lot Number: AH4104TQH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2024
• 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: 05/29/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown