MAUDE Adverse Event Report: WESTMED LLC WESTMED LLC; SUBASSEMBLY, 2L LATEX FREE BREATHING BAG WITH BLEED TAIL VALVE (BULK)

Model Number	5620006
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The holes in bag would disrupt the patient therapy, if not caught prior to use.The clinician would need to replace the circuit during the procedure causing an interruption in patient therapy.
Event or Problem Description
Holes in the breathing bags.
Additional Manufacturer Narrative
The holes in bag would disrupt the patient therapy, if not caught prior to use.The clinician would need to replace the circuit during the procedure causing an interruption in patient therapy.The defect of hole in the breathing bags was confirmed.Holes were identified along the parting line near the neck of the breathing bag.Dcr-14039 has been initiated as a result of the findings.Airlife will continue to monitor and trend complaints.
Event or Problem Description
Holes in the breathing bags.

• Brand Name: WESTMED LLC
• Common Device Name: SUBASSEMBLY, 2L LATEX FREE BREATHING BAG WITH BLEED TAIL VALVE (BULK)
• 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: 18899909
• Report Number: 2028807-2024-00003
• Device Sequence Number: 7839360
• Product Code: CAI
• UDI-Device Identifier: 00709078011689
• UDI-Public: 00709078011689
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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): 03/13/2024

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: 5620006
• Device Catalogue Number: 5620006
• Device Lot Number: 441199
• 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: Not provided
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 05/23/2024
• 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