MAUDE Adverse Event Report: WESTMED LLC ADULT SOFT TIP CANNULA WITH 7' 85 SHORE GREEN TUBING

Model Number	0556
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Tubing was black.
Additional Manufacturer Narrative
Reportable as we received the medwatch report from the fda.Will report to keep them advised of the investigation.
Additional 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 or Problem Description
Tubing was black.
Additional 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.**udi related data quality updates only**.
Event or Problem Description
Tubing was black.

• Brand Name: ADULT SOFT TIP CANNULA WITH 7' 85 SHORE GREEN TUBING
• Common Device Name: ADULT SOFT TIP CANNULA WITH 7' 85 SHORE 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
• Report Number: 2028807-2023-00033
• Device Sequence Number: 17780583
• Product Code: CAT
• UDI-Device Identifier: 00709078002960
• UDI-Public: (01)00709078002960
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Nurse Practitioner
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2024

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: 0556
• Device Catalogue Number: 0556
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2023
• Supplement Date Received by Manufacturer: 10/06/2023; 10/06/2023
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 01/15/2024; 07/23/2024
• 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