MAUDE Adverse Event Report: WESTMED LLC WESTMED LLC; INLINE MAXI HME FILTER, W/SAMPLING PORT (7-5877)

Model Number	6221
Medical Device Problem Codes	Material Fragmentation (1261); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All information reasonably known as of 30 may 2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by airlife.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to airlife.Airlife.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and identified as complaint 09528.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 airlife product is defective or caused serious injury.
Event or Problem Description
Preexisting characteristics that may have contributed to the event: one of the reinforced staple loads reinforcement was not attached and flopping all around.It wouldn't sit well when attempted to use by not lining up correctly on staple load so it wasn't used.Removed from field and another one was opened and used instead.Removed from field and given to management.No patient harm.
Additional Manufacturer Narrative
All information reasonably known as of 30 may 2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by airlife.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to airlife.Airlife.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the airlife 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 airlife product is defective or caused serious injury.No part or lot number was provided for this reported event.The event description from the fda watch report states 'one of the reinforced staple loads reinforcements was not attached and flopping all around.Device was hard to use; device failed (e.G.Broke, couldn't get it to work or stopped working' but airlife does not sell any hme/circuit/filter devices with reinforced staples.Therefore further investigation is not possible.Complaints will continue to be monitored for possible trends.
Event or Problem Description
Preexisting characteristics that may have contributed to the event: one of the reinforced staple loads reinforcement was not attached and flopping all around.It wouldn't sit well when attempted to use by not lining up correctly on staple load so it wasn't used.Removed from field and another one was opened and used instead.Removed from field and given to management.No patient harm.

• Brand Name: WESTMED LLC
• Common Device Name: INLINE MAXI HME FILTER, W/SAMPLING PORT (7-5877)
• Manufacturer (Section D): WESTMED LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer (Section G): WESTMED LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 19431147
• Report Number: 2028807-2024-00011
• Device Sequence Number: 8010571
• Product Code: CAH
• UDI-Device Identifier: 00709078000959
• UDI-Public: 00709078000959
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• 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): 07/02/2024

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 Expiration Date: 09/30/2026
• Device Model Number: 6221
• Device Catalogue Number: 6221
• Device Lot Number: N3K2598Y
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 05/30/2024
• Supplement Report FDA Received Date: 07/02/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 30 YR
• Patient Sex: Female