MAUDE Adverse Event Report: ARTERIAL CANNULA 20G/45MM; INTRAVASCULAR CATHETER

Catalog Number 682245

Device Problem Component Missing (2306)

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

Event Date 07/25/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone number: (b)(6).Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that arterial cannula 20g/45mm had a missing flow switch.The following information was provided by the initial reporter: "when the disposable infusion set was used, it was found that the infusion set regulating valve had no valve".

Manufacturer Narrative

H6: investigation summary no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified, and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that arterial cannula 20g/45mm had a missing flow switch.The following information was provided by the initial reporter: "when the disposable infusion set was used, it was found that the infusion set regulating valve had no valve".

• Brand Name: ARTERIAL CANNULA 20G/45MM
• Type of Device: INTRAVASCULAR CATHETER
• MDR Report Key: 12440602
• MDR Text Key: 270357537
• Report Number: 8041187-2021-00810
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 682245
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2021
• 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