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

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	07/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 20025053, medical device expiration date: 2023-02-01, device manufacture date: 2020-02-01; medical device lot #: 20045999, medical device expiration date: 2023-04-14, device manufacture date: 2020-04-14.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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: 20038e, batch no: 20025053 and 20045999.It was reported the tubing would not flush.We have had a handful of reports from icu nurses that at times one of the ports on our tri port extensions set are not able to flush.A nurse saved a couple of me that they found unable to flush though.I was able to flush through these devices with considerable effort.I would like to mail these two devices in to have them assessed.
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: 20038e batch no: 20025053 and 20045999 it was reported the tubing would not flush.We have had a handful of reports from icu nurses that that at times one of the ports on our tri port extensions set are not able to flush.A nurse saved a couple of me that they found unable to flush though.I was able to flush through these devices with considerable effort.I would like to mail these two devices in to have them assessed.
Additional Manufacturer Narrative
It was reported the tubing would not flush.Received from the customer is one used tri-port extension set model 20038e lot 20025053.Also received is one used tri-port extension set model 20038e lot 20045999.Both sets were visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.No anomalies were observed with the received sets.Functional testing was performed by filling a lab syringe with blue dye water and flushing fluid through each port of each set via flush.Fluid flowed throughout each set and each port with no occlusions anywhere throughout the sets.No further testing was performed as the customer¿s report was not confirmed.A device history record for model 20038e with lot number 20025053 was performed.The search showed that a total of(b)(4) units in 1 lot number were built on 01feb2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record for model 20038e with lot number 20045999 was performed.The search showed that a total of (b)(4) units in 1 lot number were built on 14apr2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The customer¿s report that the tubing would not flush was not confirmed.Functional testing of priming was successful and did not replicate any occlusions.Visual inspection also found no anomalies with the received sets h3 other text : see h10.

• Brand Name: TRI-PORT EXT W/3 VLV PORTS
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10382722
• Report Number: 9616066-2020-02370
• Device Sequence Number: 11555487
• Product Code: FPA
• UDI-Device Identifier: 07613203011976
• UDI-Public: 7613203011976
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2020

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 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: 07/24/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 10/01/2020
• 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