MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. EXT SET HI-FLOW T-CONN W/LL & 2SS; INTRAVASCULAR ADMINISTRATION SET

Model Number	C25013E
Medical Device Problem Codes	Complete Blockage (1094); Restricted Flow rate (1248)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/20/2020
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.(b)(4).
Event or Problem Description
It was reported that the ext set hi-flow t-conn w/ll & 2ss could not be flushed.The following information was provided by the initial reporter: "smart site ext set would not flush (twice) pt had to be poked twice because nurse thought it was an infiltrated line.".
Additional Manufacturer Narrative
Investigation summary no product or photo was returned by the customer.The customer complaint that the smart site extension set would not flush could not be verified due to the product not being returned for failure investigation.A device history record review for model c25013e, lot number 20087322, was performed.The search showed that a total of (b)(4), units in 1 lot number was built on (b)(6) 2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.H3 other text : see h.10.
Event or Problem Description
It was reported that the ext set hi-flow t-conn w/ll & 2ss could not be flushed.The following information was provided by the initial reporter: "smart site ext set would not flush (twice) pt had to be poked twice because nurse thought it was an infiltrated line.".

• Brand Name: EXT SET HI-FLOW T-CONN W/LL & 2SS
• 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 22244 ; MX 22244
• MDR Report Key: 10855955
• Report Number: 9616066-2020-20350
• Device Sequence Number: 14160221
• Product Code: FPA
• UDI-Device Identifier: 50885403235625
• UDI-Public: 50885403235625
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (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): 12/03/2020

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: 08/28/2023
• Device Model Number: C25013E
• Device Catalogue Number: C25013E
• Device Lot Number: 20087322
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 12/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1