MAUDE Adverse Event Report: WESTMED LLC WESTMED LLC; ADULT CANNULA SOFT TIPPED W/7' GREEN TUBING

Model Number 0556

Device Problem Material Integrity Problem (2978)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/26/2023

Event Type  malfunction  

Event Description

Tubing was black.

Manufacturer Narrative

Reportable as we received the medwatch report from the fda.Will report to keep them advised of the investigation.

Manufacturer Narrative

Reportable as we received the medwatch report from the fda.Will report to keep them advised of the investigation.There was no photos or returned inventory, complaint not confirmed.Issue stated as cannula being black.Without a lot number inventory or the dhr cannot be reviewed.In the past 24 months there have been 3 complaints related to this issue.Rma-20017a, step r10, "patient exposed to plasticizer", "soft cannula exposed to material that accelerates plasticizer migration, s=6, o=3, rpn=18, rc=1.Root cause cannot be confirmed at this time.However, it is likely that the cannula was introduced to a plasticizer it cause the cannula to oxidize and age faster, giving the black appearance.

Event Description

Tubing was black.

• Brand Name: WESTMED LLC
• Type of Device: ADULT CANNULA SOFT TIPPED W/7' GREEN TUBING
• 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: 18196864
• MDR Text Key: 328960777
• Report Number: 2028807-2023-00033
• Device Sequence Number: 1
• Product Code: CAT
• UDI-Device Identifier: 00709078002960
• UDI-Public: 00709078002960
• 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: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0556
• Device Catalogue Number: 0556
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2023
• 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