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

Catalog Number 383512

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/18/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

This complaint is mdr reportable.It was reported the bd nexiva closed iv catheter system had the ¿catheter breaking in two, it had to be surgically removed.¿.

Manufacturer Narrative

The initial mdr was submitted with an incorrect date received by manufacturer.The correct date received by manufacturer is 11/27/2017.

Manufacturer Narrative

Results: samples were received for evaluation by our quality engineer team.Upon examination, the edges of the remaining catheter tubing were observed to be smooth.Smooth edges are indicative of a sharp instrument cutting the tubing.Had the tubing been nicked, possibly during the manufacturing process, and torn due to actuation of the tubing while the device remained in the patient, the tubing would display significant jaggedness and roughness on the edges.The reported defect was not created during the manufacturing process.Had the tubing sustained the observed damaged during the manufacturing process, the unit would not have passed the 100% vision inspection for lie distance (the distance between the tip of the catheter and the bevel of the cannula) since the tubing would have completely separated from the rest of the device immediately after being cut.Furthermore, this damage occurred to the device after insertion into the patient's vasculature, otherwise the device would not have been successfully inserted without noticeable leakage.Dhr review - as no batch number was provided by the customer, a dhr review could not be performed for the returned unit.Qn database review - as no batch number was provided by the customer, a qn database review could not be performed for the returned unit.Eura review - investigation has shown that the catheter tubing was cut.The failure mode of catheter cut has been identified in (b)(4).Based on the customer's verbatim description, the effect of this failure mode is catheter fragment requiring surgical removal, which has a moderate severity of s3.Occurrence rate of this defect could not be established for the batch as no batch number was provided.However, given a remote occurrence (rarely, if ever, observed) and a moderate severity, the risk to the end user is acceptable.(b)(4) has been created to clarify the removal step and associated risks.Sample analysis - visual/microscopic examination revealed that the edges of the remaining catheter tubing were smooth.Smooth edges are indicative of a sharp instrument cutting the tubing.The customer's experience was confirmed by the returned unit.Conclusion: the smooth edges of the remaining catheter tubing indicate that the entire wall thickness of the tubing was cut with a sharp edge around the entire diameter of the tubing.Had the tubing been nicked, possibly during the manufacturing process, and torn due to actuation of the tubing while the device remained in the patient, the tubing would display significant jaggedness and roughness on the edges.The reported defect was not created during the manufacturing process.Had the tubing sustained the observed damaged during the manufacturing process, the unit would not have passed the 100% vision inspection for lie distance (the distance between the tip of the catheter and the bevel of the cannula) since the tubing would have completely separated from the rest of the device immediately after being cut.Furthermore, this damage occurred to the device after insertion into the patient's vasculature, otherwise the device would not have been successfully inserted without noticeable leakage.D16123 rev 6(c) nexiva dual port instructions for use precautions against using scissors or sharp instruments at or near the insertion site.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVENOUS CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7063686
• MDR Text Key: 93096928
• Report Number: 1710034-2017-00458
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835126
• UDI-Public: 00382903835126
• Combination Product (y/n): N
• PMA/PMN Number: K102520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383512
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 11/27/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention