MAUDE Adverse Event Report: Y EXT W/VLV PORTS & 2 SLD CLP; INTRAVASCULAR ADMINISTRATION SET

Model Number	20019E
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that 13 y ext w/vlv ports & 2 sld clp were clogged.The following information was provided by the initial reporter: customer indicating smartsite extension set sku 20019e is failing to prime and flush.No adverse result to patient or staff as a result of the incident.
Event or Problem Description
It was reported that 13 y ext w/vlv ports & 2 sld clp were clogged.The following information was provided by the initial reporter: customer indicating smartsite extension set sku 20019e is failing to prime and flush.No adverse result to patient or staff as a result of the incident.
Additional Manufacturer Narrative
Investigation summary: 13 used samples were returned by the customer for investigation.The sets were examined for defects and abnormalities.No defects or abnormalities were observed.Each sample model 20019e has 2 smartsites.Each smartsite were attached to a cut off bd syringe to see if a fluid path can be observed while the piston is in the activated position.A fluid path was observed for 23 smartsites while the piston was in the activated position.3 smartsites did not show a fluid path while the piston was in the activated position.Those 3 samples verified the customer complaint that the smartsite extension sets are failing to prime and flush.The smartsites that observed a fluid path were then connected to a 10 ml bd syringe filled with blue dye water and the set was attempted to be flushed.The set was successfully flushed.Those 23 samples did not verify the customer complaint that the smartsite extension sets are failing to prime and flush.A device history record review for model 20019e lot number 20045839 was performed.The search showed that a total of 712003 units in 1 lot number was built on 17apr2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A trend for this occlusion issue has been identified for this product line.A capa (corrective action preventative action) 1998036 has been initiated, and a team has been assembled in order to investigate the issue.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: Y EXT W/VLV PORTS & 2 SLD CLP
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12207114
• Report Number: 9616066-2021-51596
• Device Sequence Number: 4486530
• Product Code: FPA
• UDI-Device Identifier: 27613203013813
• UDI-Public: 27613203013813
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K061285
• 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,Followup
• Report Date (Section B): 07/22/2021

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 Expiration Date: 04/14/2023
• Device Model Number: 20019E
• Device Catalogue Number: 20019E
• Device Lot Number: 20045839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 08/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2020
• 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