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

Catalog Number 383517

Device Problem Split (2537)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/23/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Medical device expiration date: unknown. device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the extension tubing split in half on a bd nexiva¿ closed iv catheter system while performing an exam on a radiology patient.There was no report of exposure to mucous membranes, serious injury or medical intervention.

Event Description

"it was reported that the extension tubing split in half on a bd nexiva¿ closed iv catheter system while performing an exam on a radiology patient.There was no report of exposure to mucous membranes, serious injury or medical intervention.".

Manufacturer Narrative

Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: device returned to manufacture: yes.

Manufacturer Narrative

Investigation summary: dhr review - a review of the dhr could not be performed as no batch number was provided.Qn database review - a review of the qn database could not be performed as no batch number was provided.The cause of failure mode for tubing damage is indeterminate.Based on the customer¿s verbatim description, the effect of the device failure was leakage that did not require medical intervention.Rm5796 rev 16(o) nexiva p-eura identifies stations in the manufacturing process that can cause damage to the extension tubing resulting in leakage and states that the effect of minor leakage has a limited severity with ranking s2.The end user effect of minor leakage has occasional occurrence of o3 ( =100 ipm) for the failure mode of damaged extension tubing.The failure mode of components rupture outside the patient during power injection is identified as a failure mode in rm5769 rev 14(m) nexiva a-eura.For this failure mode, the end user effect of leakage that does not require medical intervention has a limited severity of s2 and occasional occurrence of o3 ( =100 ipm).With limited severity and occasional occurrence, the risk to the end user is acceptable.Occurrence rate of the defect for this batch could not be established as no batch information was provided.Sample analysis - the returned unit exhibits burst extension tubing.The customer's experience was confirmed.The defective unit did not display any evidence of damage due to the manufacturing process causing the extension tubing to burst.Root cause is indeterminate.Occlusion of the fluid pathway (e.G.Occluded catheter, kinked tubing, pinch clamp engaged during infusion) will increase the internal pressure of the unit and can cause the extension tubing to break, balloon, and/or burst.D16383 rev4(c) nexiva dual port instructions for use advises that measures should be taken to avoid kinking or obstructing the catheter system during power injection to avoid product failure.Burst or ballooning damage to the tubing can also occur if infusion is not performed correctly or performed at a psi/flow rate above the recommendations listed in d16383 rev4(c) nexiva dual port instructions for use.Severity is limited, and no manufacturing root cause was identified.A formal corrective action will not be initiated at this time.Customer complaint trends are evaluated on a monthly basis.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.

Event Description

It was reported that the extension tubing split in half on a bd nexiva¿ closed iv catheter system while performing an exam on a radiology patient.There was no report of exposure to mucous membranes, serious injury or medical intervention.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7518901
• MDR Text Key: 108624240
• Report Number: 1710034-2018-00199
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835172
• UDI-Public: 30382903835172
• Combination Product (y/n): N
• PMA/PMN Number: K161777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383517
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 04/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other