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	04/08/2019
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
Material no: 383538, batch no: 8186541.It was reported that during use of the bd nexiva¿ closed iv catheter system the catheter broke apart from the inserter when inserted into a patient.The following information was provided by the initial reporter: event description per attached customer email states, "hey ¿ we had a 20g nexiva cath break apart when inserted in a patient in the ed.Part # 383538 ¿ lot # 8186541.I have it in my office.I know you are out of town so will hold on to it ¿ just let me know how you want to get it.".During follow up call with customer 04/10, the event date was provided and clarification was obtained about the location of where the catheter separated (from inserter).Customer also stated that no medical intervention was needed and only additional action taken was having to restick the patient.There was blood exposure, but the staff member was wearing ppe.
Additional Manufacturer Narrative
Investigation: our quality engineer inspected the sample submitted for evaluation.Bd received one nexiva 20ga catheter adapter extension set assembly along with a needle cover, 2 vent plugs and a blue cap.Through the visual/microscopic evaluation the extension tubing was found to be disconnected from the winged adapter port.There were no traces of adhesive present on the extension tubing.Your reported issue was confirmed as there was not sufficient adhesive in the extension tubing/ adapter joint.This was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect relating to an insufficient amount of adhesive dispensed in the tubing/adapter port joint.Corrective actions, capa#684099, have been initiated to monitor the reported issue.
Event or Problem Description
Material no: 383538, batch no: 8186541.It was reported that during use of the bd nexiva¿ closed iv catheter system the catheter broke apart from the inserter when inserted into a patient.The following information was provided by the initial reporter: event description per attached customer email states, "hey, we had a 20g nexiva cath break apart when inserted in a patient in the ed.Part # 383538, lot # 8186541.I have it in my office.I know you are out of town so will hold on to it, just let me know how you want to get it." during follow up call with customer 04/10, the event date was provided and clarification was obtained about the location of where the catheter separated (from inserter).Customer also stated that no medical intervention was needed and only additional action taken was having to restick the patient.There was blood exposure, but the staff member was wearing ppe.
Event or Problem Description
Material no: 383538, batch no: 8186541.It was reported that during use of the bd nexiva¿ closed iv catheter system the catheter broke apart from the inserter when inserted into a patient.The following information was provided by the initial reporter: event description per attached customer email states, "hey ¿ we had a 20g nexiva cath break apart when inserted in a patient in the ed.Part # 383538 ¿ lot # 8186541.I have it in my office.I know you are out of town so will hold on to it ¿ just let me know how you want to get it." during follow up call with customer 04/10, the event date was provided and clarification was obtained about the location of where the catheter separated (from inserter).Customer also stated that no medical intervention was needed and only additional action taken was having to restick the patient.There was blood exposure, but the staff member was wearing ppe.
Additional Manufacturer Narrative
Pma / 510(k) #: k183399.

• 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: 8560633
• Report Number: 1710034-2019-00465
• Device Sequence Number: 2346618
• 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,Followup
• Report Date (Section B): 06/21/2019

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: 383538
• Device Lot Number: 8186541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 04/09/2019; 04/09/2019
• Initial Report FDA Received Date: 04/29/2019
• Supplement Report FDA Received Date: 06/06/2019; 06/25/2019
• 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