MAUDE Adverse Event Report: WESTMED WESTMED; ADAPTOR, 22/15MM X 22MM OD, BULK(100/CS),

Model Number 7-5105

Device Problem Moisture Damage (1405)

Patient Problem Insufficient Information (4580)

Event Date 01/06/2022

Event Type  malfunction  

Manufacturer Narrative

Moisture causing them to get stuck so, they would break apart or must be thrown out.The adapter is a component of a ventilator circuit and the incident occurred during use.Base on the reported information the criteria for reporting an adverse event has been met.

Event Description

Moisture causing them to get stuck, so they would break apart or have to be thrown out.

Event Description

Moisture causing them to get stuck so they would break apart or have to be thrown out.

Manufacturer Narrative

Moisture causing them to get stuck so they would break apart or must be thrown out.The adapter is a component of a ventilator circuit and the incident occurred during use.Base on the reported information the criteria for reporting an adverse event has been met.Complaint confirmed via testing of lot# 010422u26.22mm od side of adaptor is not iso spec, but actually 0.875" as noted on drawing 24011.Ncmr-02278 has been opened to address molding issues.Customer informed of nonconformance.Issue has been sent for carb review due to loss of intended function from being out of tolerance.

• Brand Name: WESTMED
• Type of Device: ADAPTOR, 22/15MM X 22MM OD, BULK(100/CS),
• Manufacturer (Section D): WESTMED; 5580 s nogales highway; tucson AZ 85706
• Manufacturer (Section G): WEST MED; 5580 s nogales highway; tucson AZ 85706
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 13573197
• MDR Text Key: 288683467
• Report Number: 2028807-2022-00006
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7-5105
• Device Lot Number: 100520N01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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