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

Catalog Number 383511

Device Problem Malposition of Device (2616)

Patient Problem Infiltration into Tissue (1931)

Event Date 04/25/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device evaluated by mfr: a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that bd nexiva¿ closed iv catheter system infiltrated.The following information was provided by the initial reporter: material no.: 383511, batch no.: unknown.It was reported that the iv infiltrated the patient's right hand.Per medwatch: an iv was started for a patient while in the emergency department who required a blood transfusion.Pump had been infusing and had alarmed when a healthcare professional was in the room and noted the infiltration.The patient developed an iv infiltrate and right hand compartment syndrome requiring a fasciotomy of the right hand and forearm.Patient is currently being followed by plastic surgery.

Manufacturer Narrative

The following fields have been updated with corrections: pma/510(k)#: k183399.

Event Description

It was reported that bd nexiva¿ closed iv catheter system infiltrated.The following information was provided by the initial reporter: material no.383511 batch no.Unknown.It was reported that the iv infiltrated the patients right hand.Per medwatch: an iv was started for a patient while in the emergency department who required a blood transfusion.Pump had been infusing and had alarmed when a healthcare professional was in the room and noted the infiltration.The patient developed an iv infiltrate and right hand compartment syndrome requiring a fasciotomy of the right hand and forearm.Patient is currently being followed by plastic surgery.

Event Description

It was reported that bd nexiva¿ closed iv catheter system infiltrated.The following information was provided by the initial reporter: material no.383511; batch no.Unknown.It was reported that the iv infiltrated the patients right hand.Per medwatch: an iv was started for a patient while in the emergency department who required a blood transfusion.Pump had been infusing and had alarmed when a healthcare professional was in the room and noted the infiltration.The patient developed an iv infiltrate and right hand compartment syndrome requiring a fasciotomy of the right hand and forearm.Patient is currently being followed by plastic surgery.

Manufacturer Narrative

Investigation summary: bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch, or lot code was provided.This complaint will be entered into the complaint management system and will be tracked & trended for future occurrences.The complaint was deemed as mdr reportable therefore a submission will be performed.Shall a sample or lot number become available, the complaint will be re-opened and an investigation will take place.This complaint will be closed at this time.

Event Description

It was reported that bd nexiva¿ closed iv catheter system infiltrated.The following information was provided by the initial reporter: material no.: 383511 batch no.: unknown.It was reported that the iv infiltrated the patient's right hand.Per medwatch: an iv was started for a patient while in the emergency department who required a blood transfusion.Pump had been infusing and had alarmed when a healthcare professional was in the room and noted the infiltration.The patient developed an iv infiltrate and right hand compartment syndrome requiring a fasciotomy of the right hand and forearm.Patient is currently being followed by plastic surgery.

Manufacturer Narrative

Date of event: on (b)(6) 2019.

• 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: 8701493
• MDR Text Key: 148077623
• Report Number: 1710034-2019-00630
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835110
• UDI-Public: 30382903835110
• Combination Product (y/n): N
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/08/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 383511
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/30/2019
• Initial Date FDA Received: 06/14/2019
• Supplement Dates Manufacturer Received: 05/30/2019; 05/30/2019; 05/30/2019
• Supplement Dates FDA Received: 06/19/2019; 06/26/2019; 07/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention