MAUDE Adverse Event Report: WESTMED LLC WESTMED LLC; OXYGEN TUBING 7', MCKESSON

Model Number	32647
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The tubing not attaching would cause an interruption in therapy.If the event were to occur during patient use, they could become hypoxic.
Event or Problem Description
Oxygen tubing pulling out of concentrator connector.
Event or Problem Description
Oxygen tubing pulling out of concentrator connector.
Additional Manufacturer Narrative
The tubing not attaching would cause an interruption in therapy.If the event were to occur during patient use, they could become hypoxic.The complaint reported that "oxygen tubing pulling out of concentrator connector." the complaint investigation was performed based on the content of the issue reported.Based on the complaint report no patient was affected.The potential root cause may have been due to improper handling of the product.A risk assessment was performed, and the ultimate risk was determined to be low which does not require reporting to the capa review board.This is the first (1) complaint reported for part number 32647 failure mode "disconnecting tube", no other complaints were reported.We will continue to monitor trends during our periodic complaint review meetings.

• Brand Name: WESTMED LLC
• Common Device Name: OXYGEN TUBING 7', MCKESSON
• 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: 18909185
• Report Number: 2028807-2024-00008
• Device Sequence Number: 7042789
• Product Code: BYX
• UDI-Device Identifier: 20612479203758
• UDI-Public: 20612479203758
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2024

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: 32647
• Device Catalogue Number: 32647
• Device Lot Number: MWM441358
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2024
• Supplement Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 04/18/2024
• 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 Sex: Unknown