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

Catalog Number	383538
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/21/2018
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 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 the extension set separated from the connection with the base of the bd nexiva¿ closed iv catheter system.There was no report of exposure, injury, or medical intervention.
Additional Manufacturer Narrative
H.6.Investigation summary: dhr review was performed on lot number 8186541; the lot number was built / packaged on nfa line #1 from (b)(6)2018 thru (b)(6)2018.Review of dhr revealed all required challenge samples, set-up and in process testing was performed in accordance with the quality plans.Review disclosed no reject activity findings throughout the build of this lot that would impact the outcome of the quality of the product relevant to the defect stated in the pir.No quality notification were initiated during the build of this lot number.Received one used nexiva 20 ga unit in an opened package from the lot number 8186541.The unit consisted of the catheter adapter/extension set assembly and the needle set assembly.Bodily fluids in the catheter tubing and extension tubing.The extension tubing was separated from the clear port of the catheter adapter.No adhesive was found on the extension tubing or around or in the clear port of the catheter adapter.Conclusion(s): manufacturing ¿ this defect was created at the zone 8 adhesive dispense station after the station redesign.If air got in the lines that fed adhesive to the adhesive dispense grippers, a short shot of adhesive would be dispensed onto the tube.A new station design was installed on nfa1 zone (b)(6) 2018 (protocol (b)(4) that the extension tube adhesive dispense stations are purged on a regular basis and current process controls include routine leak test and ext.Pull test well as a 100% online flow tester in zone 8.Corrective actions: vision upgrades to better detect the new failure modes from the station redesign ¿ (b)(6) 2018.Design and install tooling to make the station (adhesive dispense tips) more robust ¿ (b)(6)2018.Cpm for batch for that defect = 37.2 (occasional occurrence).
Event or Problem Description
It was reported that the extension set separated from the connection with the base of the bd nexiva¿ closed iv catheter system.There was no report of exposure, injury, or medical intervention.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER 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: 7965607
• Report Number: 1710034-2018-00724
• Device Sequence Number: 1213987
• Product Code: FOZ
• UDI-Device Identifier: 30382903835387
• UDI-Public: 30382903835387
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K161777
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2018

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: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 383538
• Device Lot Number: 8186541
• Initial Date Received by Manufacturer: 09/21/2018
• Supplement Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 10/15/2018
• Supplement Report FDA Received Date: 11/27/2018
• 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