MAUDE Adverse Event Report: CAREFUSION MICRO EXT SET W/1 SS VLV; INTRAVASCULAR ADMINISTRATION SET

Model Number	10010983
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 micro ext set w/1 ss vlv was defective.The following information was provided by the initial reporter: material no: 10010983, batch(lot) no: 20055744.It was reported that bd smart sites have been defective (unknown reason-pending customer response).I am reaching out because a nurse manager in our vascular access department has reached out about product 10010983 (bd smart sites).They have recently been defective and i have been receiving reports for lot number 20055744.
Additional Manufacturer Narrative
It was reported that bd smart sites have been defective.Received from the customer is one used extension set model 10010983 lot 20055744.The set was visually inspected for kinks, holes/tears in the tubing or damages to the components.No anomalies were observed on the set during initial visual inspection.Functional testing was performed by using a lab syringe and attaching it to the smartsite port on the set allowing fluid to flow through the whole set by flush.Flushing the smartsite port (p/n 620-00160) was met with an occlusion.Bd manufacturing is aware of smartsite occlusion issues and is currently investigating the root cause under capa 1998036.A device history record for model 10010983 with lot number 20055744 was performed.The search showed that a total of (b)(4) units in 1 lot number were built on 28may2020.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 of defective smartsite was confirmed to be an occlusion.The root cause of the occlusion could not be determined.H3 other text : see h10.
Event or Problem Description
It was reported that micro ext set w/1 ss vlv was defective.The following information was provided by the initial reporter: material no: 10010983, batch(lot) no: 20055744.It was reported that bd smart sites have been defective (unknown reason-pending customer response).I am reaching out because a nurse manager in our vascular access department has reached out about product 10010983 (bd smart sites).They have recently been defective and i have been receiving reports for lot number 20055744.

• Brand Name: MICRO EXT SET W/1 SS VLV
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10477747
• Report Number: 9616066-2020-02669
• Device Sequence Number: 14111230
• Product Code: FPA
• UDI-Device Identifier: 10885403233579
• UDI-Public: 10885403233579
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2020

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: 05/28/2023
• Device Model Number: 10010983
• Device Catalogue Number: 10010983
• Device Lot Number: 20055744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 11/10/2020
• 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