MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SINGLE-PORT SYSTEM; INTRAVASCULAR CATHETER

Catalog Number	383518
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2019
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.
Event or Problem Description
It was reported that after use of the bd nexiva¿ closed iv catheter single-port system the nexiva extension set disconnected from the stabilization platform/hub.
Additional Manufacturer Narrative
H.6.Investigation: during dhr review all required challenge samples, set-up and in process testing was performed in accordance with the quality plans.Review disclosed one non-related qn was initiated on this lot that would not impact the outcome of the quality of the product relevant to the defect stated in the pir.Although units were not returned for investigation, one photo was provided for evaluation of this incident, o the photo revealed a used 20ga nexiva closed iv catheter system single port unit that consisted of the catheter/adapter and extension tubing assemblies and had traces of thick media.O photo shown that there was a needless injection site attached at each of the port (luer) and the pinch clamp was disengaged.O the photo also shown that the extension tubing was disconnected from the winged adapter (stabilization platform).Visual/microscopic evaluation: the photo displayed that the unit had separation of the extension tubing from within the clear port of the winged adapter (stabilization platform).No further damage was observed.Batch 8186538 was produced prior to the zone 8 adhesive station redesign.In the previous station design, this defect was created at the zone 8 adhesive dispense station if air got into the lines that feed adhesive to the adhesive dispense grippers, causing a short shot of adhesive to be dispensed onto the tube.Capa#684099 was initiated.
Event or Problem Description
It was reported that after use of the bd nexiva¿ closed iv catheter single-port system the nexiva extension set disconnected from the stabilization platform/hub.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SINGLE-PORT SYSTEM
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8433432
• Report Number: 1710034-2019-00304
• Device Sequence Number: 16202983
• Product Code: FOZ
• UDI-Device Identifier: 30382903835189
• UDI-Public: 30382903835189
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161777
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 383518
• Device Lot Number: 8186538
• Initial Date Received by Manufacturer: 03/01/2019
• Supplement Date Received by Manufacturer: 03/01/2019
• Initial Report FDA Received Date: 03/19/2019
• Supplement Report FDA Received Date: 05/21/2019
• 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