MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. TRI-PORT EXT SET W/LL DEHP FREE; INTRAVASCULAR ADMINISTRATION SET

Model Number	10839681
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2021
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 the tri-port ext set w/ll dehp free leaked during use.The following information was provided by the initial reporter: "we have received notice from out clinicians that the following product was leaking.".
Event or Problem Description
It was reported that the tri-port ext set w/ll dehp free leaked during use.The following information was provided by the initial reporter: "we have received notice from out clinicians that the following product was leaking.".
Additional Manufacturer Narrative
H6: investigation summary: the customer reported the product was leaking, and returned two used trifurcate samples.The two samples both had a leak and the complaint was verified.The first one leaked from a small hole in the tubing leading into the lone spin collar luer.This failure had plenty of solvent and a good insertion depth, the leak came from a tear in the tubing - picture attached.The second one leaked from one of the three female luer/needleless connector joints.Under the microscope, the leaking needleless appeared to be damaged when compared to one that did not leak.The female luer appeared to be undamaged.The root cause is damaged needleless connector.The material # for the purple needleless connector was not known.No other failure modes were observed.A device history record review for model 10839681 lot number 21016572 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 21jan2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.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: TRI-PORT EXT SET W/LL DEHP FREE
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• MDR Report Key: 12112014
• Report Number: 9616066-2021-51448
• Device Sequence Number: 14466191
• Product Code: FPA
• UDI-Device Identifier: 50885403234536
• UDI-Public: 50885403234536
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• 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): 07/08/2021

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: 01/27/2024
• Device Model Number: 10839681
• Device Catalogue Number: 10839681
• Device Lot Number: 21016572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2021
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 07/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1