MAUDE Adverse Event Report: O&M HALYARD, INC. AEROBLUE BREATHABLE SURGICAL GOWN STERILE

Model Number	41734
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Samples have been received; sample evaluation is pending.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.
Event or Problem Description
The staff was preparing to setup a room for surgery and noticed a strong smell.The or had to be shut down due to the smell as the facility was unsure where the smell was coming from.Staff member(s) became ill from the smell.The facility mentioned they have a device that could be used to determine the parameter of gas or eo and the device had no indication that the or was compromised by such chemicals.The clinician determined the smell was not coming from anesthesia and later alleged the smell was coming from the aeroblue gown.Additional details regarding staff member medical intervention and status were requested, the customer respondent indicated these details were unknown.
Additional Manufacturer Narrative
Three (3) samples were received for this lot number in the product packaging.Upon arrival, the samples were noted to have a smell similar to a gas or eo (ethylene oxide) smell.All results were found to be within acceptance criteria.Device history record (dhr) evaluation was conducted.The reviewed information confirmed that the lot was manufactured in accordance with specification.There are no non-conformances nor reworks related to the failure mode described.The certificate of analysis/conformance provided by the raw material suppliers was reviewed and it confirms that the fabric was manufactured according to specifications.An incoming inspection was performed of raw materials (fabric, gown and packaging components) upon receipt.Inspection includes attributes and dimensional verifications.No abnormalities were found.An interview process was done with personnel at manufacturing areas to identify if there have been any reports of strong odor on fabric or other raw material components during production timeframe.There have not been any reports of odor.Good manufacturing practices are followed in the manufacturing areas.Every employee is trained in gmps as part of the required trainings.Based on the investigation performed and the results obtained from sample evaluations, no root cause was identified.Actions taken: 1.Manufacturing lean teams of aero blue surgical gowns were notified of customer complaints received with the objective of raising awareness.2.Complaint data will be monitored to identify upward trends associated with the reported incident/family.3.A root cause analysis kaizen will be conducted to further try and identify root cause for smell.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: AEROBLUE BREATHABLE SURGICAL GOWN STERILE
• Common Device Name: SURGICAL GOWN
• Manufacturer (Section D): O&M HALYARD, INC.; 1220 old alpharetta rd; ste 320; alpharetta GA 30005
• Manufacturer (Section G): O&M HALYARD HONDURAS S.A DE C.; carretera tegucigalpa; villaneva cortes, hn ; HO
• Manufacturer Contact: nichole coggins ; 1220 old alpharetta rd; ste 320; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 20140621
• Report Number: 9680646-2024-00008
• Device Sequence Number: 7417607
• Product Code: FYA
• UDI-Device Identifier: 30680651417344
• UDI-Public: 30680651417344
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 12/11/2024

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: 41734
• Device Catalogue Number: 104173401
• Device Lot Number: AH4174TZN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2024
• 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: 08/23/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 12/11/2024
• 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
• Patient Sex: Unknown