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	06/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 y ext w/vlv ports & 2 sld clp sets had blockage and couldn't be flushed.The following information was provided by the initial reporter: "i was alerted yesterday by our nm rn that smartsite ext sets were not flushing it seemed to be isolated to lot.".
Event or Problem Description
It was reported that y ext w/vlv ports & 2 sld clp sets had blockage and couldn't be flushed.The following information was provided by the initial reporter: "i was alerted yesterday by our nm rn that smartsite ext sets were not flushing it seemed to be isolated to lot.".
Additional Manufacturer Narrative
H6: investigation summary: one sample (model #20019e) was returned by the customer.It was reported that the extension set was not flushing.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The sample was connected to a cut off syringe tip to check that the fluid path is in an activated position/open when connected to a syringe.The sample was then attempted to be flushed with water using a 10ml bd syringe to confirm an open fluid path.The fluid path of the sample was open and that sample was able to be flushed.The failure was unable to be replicated, and the complaint could not be verified.A device history record review for model 20019e lot number 21026326 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 22feb2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to an increase in incidents of this failure mode, 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.
Event or Problem Description
It was reported that y ext w/vlv ports & 2 sld clp sets had blockage and couldn't be flushed.The following information was provided by the initial reporter: "i was alerted yesterday by our nm rn that smartsite ext sets were not flushing it seemed to be isolated to lot".
Additional Manufacturer Narrative
The following field was updated due to corrected information: h.1.No.Of events summarized: not applicable.This field was mistakenly completed in the initial submission.The report is not intended to be a voluntary malfunction summary report, but a single reported event.

• Brand Name: Y EXT W/VLV PORTS & 2 SLD CLP
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12243088
• Report Number: 9616066-2021-51640
• Device Sequence Number: 3611645
• Product Code: FPA
• UDI-Device Identifier: 27613203013813
• UDI-Public: 27613203013813
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K061285
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/20/2021

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: Health Professional
• Device Expiration Date: 02/21/2024
• Device Model Number: 20019E
• Device Catalogue Number: 20019E
• Device Lot Number: 21026326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Initial Date Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 08/04/2021; 09/30/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 08/18/2021; 10/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2021
• 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