MAUDE Adverse Event Report: CAREFUSION TRI-PORT EXT W/3 VLV PORTS; INTRAVASCULAR ADMINISTRATION SET

Model Number	20038E
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	08/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that tri-port ext w/3 vlv ports were blocked.The following information was provided by the initial reporter: material no: batch no: unknown.It was reported that there was difficulty flushing/priming.
Event or Problem Description
It was reported that tri-port ext w/3 vlv ports were blocked.The following information was provided by the initial reporter: material no: batch no: unknown.It was reported that there was difficulty flushing/priming.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d4: medical device lot #: 20045997.D4: medical device lot #: unknown.D4: medical device expiration date: 04/11/2023.D4: medical device expiration date: unknown.D10: device available for eval yes, d10: returned to manufacturer on: 09/15/2020.H4: device manufacture date: 04/11/2020.H4: device manufacture date: unknown.Investigation conclusion it was reported that the sets had difficulty flushing/priming.Received three used extension set model 20038e lot 20045997 with three packaging pouches (set 1-4).Also, received three used extension set model 20038e lot unknown (set 5-7).The sets were visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Further inspection was performed under magnification and found no visible damages, occlusions, or any issues were observed with the sets.Functional testing was performed by attaching a 10ml lab syringe filled with blue dye water to each of the sets¿ smartsites.The syringe plunger was gently depressed and the sets reprimed successfully with no flow resistance, occlusions, or any issues.Equipment used (inspection performed on (b)(6) 2020) - optical ram-cnc, eq08204, calibration due date: 05feb2021 a device history record for model 20038e with lot number 20045997 was performed.The search showed that a total of (b)(4) units were built in 1 lot on 11apr2020.The search showed that there were no quality notifications for the failure mode reported by the customer.A device history record could not be performed for the sets with lot unknown due to no lot number was provided by the customer.The customer report that the sets had difficulty flushing/priming was not confirmed.The root cause of the customer¿s experience was not identified as the sets reprimed/flushed with no evidence of occlusions or any issues.H3 other text : see h10.

• Brand Name: TRI-PORT EXT W/3 VLV PORTS
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10531905
• Report Number: 9616066-2020-02718
• Device Sequence Number: 14123173
• Product Code: FPA
• UDI-Device Identifier: 07613203011976
• UDI-Public: 7613203011976
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2020

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: Other
• Device Expiration Date: 04/11/2023
• Device Model Number: 20038E
• Device Catalogue Number: 20038E
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 10/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other