MAUDE Adverse Event Report: WESTMED LLC WESTMED; 120" ADULT UNI-LIM ELBOW,MAXIHMEF,ISGL,3LF,6' .050 M/M GSL

Model Number 9566

Device Problem Particulates (1451)

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 07/24/2023

Event Type  malfunction  

Manufacturer Narrative

Particulates on the patients side of the filter would delay in respiratory therapy and expose them foreign material that could cause harm.This would also delay ventilation as clinician would need to replace with one that does not have particulates on the patient side of filter.Although there was no patient harm due to the filter being replaced and the healthcare personnel were able to provide ventilation to the patient this event will be reported.Based on this information this is a reportable event.

Event Description

Plastic membranes found in the patient side of the airway filter.

Manufacturer Narrative

Particulates on the patients side of the filter would delay in respiratory therapy and expose them foreign material that could cause harm.This would also delay ventilation as clinician would need to replace with one that does not have particulates on the patient side of filter.Although there was no patient harm due to the filter being replaced and the healthcare personnel were able to provide ventilation to the patient this event will be reported.Based on this information this is a reportable event.He complaint of "plastic membranes found in the patient side of the airway filter" regarding part 9566 was confirmed via photo.The root cause cannot be determined but could possibly be a result of "occlusions in tubing, filters and/or connectors".A risk assessment was performed and the ultimate risk was determined to be medium which does not require the initiation of a capa.There have been 0 other complaints were regarding the same part and a similar issue within the 24 months preceding this complaint.A resolution letter was sent to the customer.

Event Description

Plastic membranes found in the patient side of the airway filter.

• Brand Name: WESTMED
• Type of Device: 120" ADULT UNI-LIM ELBOW,MAXIHMEF,ISGL,3LF,6' .050 M/M GSL
• 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: 17615121
• MDR Text Key: 321921595
• Report Number: 2028807-2023-00024
• Device Sequence Number: 1
• Product Code: CAH
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9566
• Device Catalogue Number: 9566
• Device Lot Number: 23188
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/25/2023
• 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