MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA DUAL PORT 20GA 1.75IN (1.1 MM X 45 MM); INTERVASCULAR CATHETER

Catalog Number	383538
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter occupation: director supply chain logistics & capital mgmt.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 an unspecified number of bd nexiva dual port 20ga 1.75in (1.1 mm x 45 mm) experienced a catheter that broke/separated from the hub during use.The following information was provided by the initial reporter: material no: 383538, batch no: 8186541.Per customer email: hey, another one disconnected or broke apart when used on a patient.Item number (383538), lot number (8186541).
Event or Problem Description
It was reported that an unspecified number of bd nexiva dual port 20ga 1.75in (1.1 mm x 45 mm) experienced a catheter that broke/separated from the hub during use.The following information was provided by the initial reporter: material no: 383538, batch no: 8186541.Per customer email: hey, another one disconnected or broke apart when used on a patient.Item number: (383538), lot number: (8186541).
Additional Manufacturer Narrative
H.6.Investigation summary: received a 20ga nexiva catheter-adapter extension set within an open package from lot: 8186541.A review of the device history record revealed no irregularities during the manufacture of the reported lot.The extension tubing was received in 2 portions: the extension tubing was disconnected from the winged adapter.Traces adhesive were observed at the end of the extension tubing.Traces of adhesive were observed outside of the adapter port.Conclusion: the device failure was due to an insufficient amount of adhesive in the extension tubing/ adapter joint.This defect is created at the new zone 8 adhesive dispense station.When the adhesive dispense tips become misaligned, adhesive is not dispensed in the proper location leading to an insufficient amount of adhesive in the tubing/adapter port joint.This failure mode of the process was introduced by the new station design, and the 100% adhesive presence vision system was not capable of detecting these failures.The manufacturing department identified the issue and took immediate corrective action on 11 sep 2018 by upgrading the vision system on both production lines to be able to detect adhesive that was not in the correct location.Holders for the adhesive dispense tips were added to the machine on 26 sep 2018 to better protect the tips from damage and becoming misaligned.Capa: 684099 to further investigate this issue was completed on 26apr2019.The lot in question was produced before the completion of the corrective action, therefore a new corrective action is not warranted as no new trends for this defect have been identified post-capa.H3 other text.

• Brand Name: BD NEXIVA DUAL PORT 20GA 1.75IN (1.1 MM X 45 MM)
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8782106
• Report Number: 1710034-2019-00759
• Device Sequence Number: 11272310
• Product Code: FOZ
• UDI-Device Identifier: 30382903835387
• UDI-Public: 30382903835387
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2019

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: 383538
• Device Lot Number: 8186541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 09/16/2019
• 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