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

Catalog Number 383536

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Needle Stick/Puncture (2462)

Event Date 11/24/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

When using the bd nexiva¿ closed iv catheter system with dual port a nurse had inserted a pink nexiva cannula into a patient.She then started the removal process of the needle and pulled the needle but did not hear a 'click' from the safety activation device.When placing the needle in sharps bin, the grey safety activation was not activated and slid down to the base a needle-stick injury occurred.

Manufacturer Narrative

Eighty sample units within sealed packages were provided for evaluation by our quality engineer team.Upon examination, no mechanical or physical damage was observed on any of the components.Functionality testing was performed by manually disengaging and retracting the units.All of the tested units retracted successfully.Based on the sample unit investigation, our quality team was unable to confirm the reported defects of safety shield activation failure and needle stick injury, therefore a root cause could not be determined.A device history record review showed no rejected inspections or quality notifications on the provided batch number that could have contributed to the reported defects.Product quality is evaluated during the manufacturing process with prescribed variables and attributes inspections.These inspections are performed by operators and process control technicians to ensure any gross process changes are identified.All samples and challenges were performed as intended and none relating to the function of the safety mechanism.No qns were initiated for failure of the safety mechanism.The cause of the safety mechanism failure can be alignment of the machine during assembly.The occurrence and severity of this incident does not exceed what is allowable representative sample analysis: no defects were identified.A device history record review showed no rejected inspections or quality notifications on the provided batch number that could have contributed to the reported defects of safety shield activation failure and needle stick injury.80 sample units within sealed packages were provided for evaluation by our quality engineer team.Upon examination, no mechanical or physical damage was observed to any of the components.Functionality testing was performed by manually disengaging and retracting the units.All of the tested units retracted within specifications.Based on the sample unit investigation, our quality team was unable to confirm the reported defects and therefore a root cause could not be determined.Product quality is evaluated during the manufacturing process with prescribed variables and attributes inspections.These inspections are performed by operators and process control technicians to ensure any gross process changes are identified.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH DUAL PORT
• Type of Device: INTRAVASCULAR CATHETER SINGLE PORT
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7126076
• MDR Text Key: 95175280
• Report Number: 1710034-2017-00461
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835363
• UDI-Public: 30382903835363
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K102520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2018

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: Nurse
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 383536
• Device Lot Number: 7131593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2017
• Initial Date FDA Received: 12/18/2017
• Supplement Dates Manufacturer Received: 11/24/2017
• Supplement Dates FDA Received: 01/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention