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

Model Number 5620006

Device Problem Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/13/2024

Event Type  malfunction  

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 Description

Holes in the breathing bags.

• Brand Name: WESTMED LLC
• Type of Device: 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
• MDR Text Key: 337640008
• Report Number: 2028807-2024-00003
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 00709078011689
• UDI-Public: 00709078011689
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other