MAUDE Adverse Event Report: NDLELESS VLV ADPT ARTERIAL; INTRAVASCULAR ADMINISTRATION SET

Model Number	2000EA
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: no product or photo was returned by the customer.The customer complaint of 2000ea adaptor is leaking fluid could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 2000ea because a valid lot number was not provided by the customer.The root cause of this failure could not be identified without a failure investigation.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: due to no sample being received, an investigation could not be performed, and a root cause could not be determined.
Event or Problem Description
It was reported that the ndleless vlv adpt arterial experienced leakage.The following information was provided by the initial reporter: i had a report from the charge nurse of some concerning issue when they had a texium adaptor connected to a 2000ea adaptor.Apparently there was a leak while fluid was passing between the two, but i have reports they had been using one of the 2000ea on the picc to check for blood return.

• Brand Name: NDLELESS VLV ADPT ARTERIAL
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12389086
• Report Number: 9616066-2021-51925
• Device Sequence Number: 4724646
• Product Code: FPA
• UDI-Device Identifier: 27613203021689
• UDI-Public: 27613203021689
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/04/2021

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: Other
• Device Model Number: 2000EA
• Device Catalogue Number: 2000EA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 08/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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