MAUDE Adverse Event Report: CAREFUSION AS SYR PSD ASV 20D SMBORE SS 0.2M CV; INTRAVASCULAR ADMINISTRATION SET

Model Number	10798696
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	08/03/2020
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 as syr psd asv 20d smbore ss 0.2m cv tubing was occluded.The following information was provided by the initial reporter: material no:10798696 batch no: unknown.It was reported that tubing occluded.
Additional Manufacturer Narrative
The following fields were updated due to additional information: b5: describe event or problem it was reported that as syr psd asv 20d smbore ss 0.2m cv tubing was occluded.The following information was provided by the initial reporter: material no:10798696 batch no: 20026497 it was reported that tubing occluded.D4 lot# 20026497 d.4.Medical device expiration date: 2023-02-25 d10 device available for eval yes, d10 returned to manufacturer on: 09/14/2020 h.4.Device manufacture date: 2020-02-25 investigation conclusion it was reported that the tubing occluded.Received twenty new syringe sets 10798696 lot 20026497.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.No visible damages or issues were observed with the sets.Functional testing was performed by spiking the sets to a lab iv bag filled with blue dye water and attaching a 1ml lab syringe to the set¿s smartsite per directions for use.A 22g cannula was attached to the sets¿ male luers.The syringe plunger was gently pulled allowing the fluid from the bag to prime the sets passed the check valves.The syringe plunger was then depressed to completely prime the sets.The sets primed successfully with no occlusions, leaks, or any issues.The sets were loaded into a lab syringe module and programmed for an infusion for 1ml/hr and vtbi of 0.15ml.The infusions completed with no alarms or any issues.The sets were pressure tested while submerged underwater (per dir # 10000360033 ¿ iv disposable leak test method).Air pressure was incrementally increased.Pressure was increased from 5 to 30 psi and no occlusions or leaks were observed.Equipment used (testing performed on (b)(6) 2020) - air pressure regulator with pressure gauge, eq00151, calibration due date: 07nov2020 - 8015 alaris pcu 1.5, eq10291, calibration due date: 20mar2021 - 8100 alaris system syringe, eq08313, calibration due date: 04aug2021 a device history record for model 10798696 with lot number 20026497 was performed.The search showed that a total of (b)(4) units were built in 1 lot on 25feb2020.The search showed that there were no quality notifications for the failure mode reported by the customer.The customer's report that the tubing occluded was not confirmed.The root cause of the customer¿s experience was not identified as the set primed and infused completely with no occlusions or any issues.H3 other text : see h10.
Event or Problem Description
It was reported that as syr psd asv 20d smbore ss 0.2m cv tubing was occluded.The following information was provided by the initial reporter: material no:10798696.Batch no: 20026497.It was reported that tubing occluded.

• Brand Name: AS SYR PSD ASV 20D SMBORE SS 0.2M CV
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10444465
• Report Number: 9616066-2020-02514
• Device Sequence Number: 11777327
• Product Code: FPA
• UDI-Device Identifier: 10885403234354
• UDI-Public: 10885403234354
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2020

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: 02/25/2023
• Device Model Number: 10798696
• Device Catalogue Number: 10798696
• Device Lot Number: 20026497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 10/21/2020
• 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