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

Catalog Number 383512

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Hemolysis (1886)

Event Date 08/01/2019

Event Type  malfunction  

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

It was reported that blood unable to/or drew very slow which lead to hemolyzed specimen with a bd nexiva¿ closed iv catheter system.The following information was provided by the initial reporter: (2 of 5) catheter was in the vein and would not draw blood/ or drew very slow to hemolyze specimen.Blue needless transfer device nor syringe did not work to draw blood/ or drew very slow to lead to hemolysis and patient being stuck additional times for blood.Iv catheter flushed without problems.Catheter was discarded after being removed from patient, but additional product information provided below.This event required patient to be stuck an additional time for iv placement and blood draw.

Manufacturer Narrative

Investigation summary: there were no samples or photos available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.The manufacturing facility has been notified of this event but without a sample no corrective actions could be identified.A review of the device history record was performed and no quality issues were found during production.

Event Description

It was reported that blood unable to/or drew very slow which lead to hemolyzed specimen with a bd nexiva¿ closed iv catheter system.The following information was provided by the initial reporter: (2 of 5) catheter was in the vein and would not draw blood/ or drew very slow to hemolyze specimen.Blue needless transfer device nor syringe did not work to draw blood/ or drew very slow to lead to hemolysis and patient being stuck additional times for blood.Iv catheter flushed without problems.Catheter was discarded after being removed from patient, but additional product information provided below.This event required patient to be stuck an additional time for iv placement and blood draw.

• 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: 8937488
• MDR Text Key: 157461000
• Report Number: 1710034-2019-00933
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835127
• UDI-Public: 30382903835127
• Combination Product (y/n): N
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 09/05/2019

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: Other
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 383512
• Device Lot Number: 9137627
• Initial Date Manufacturer Received: 08/09/2019
• Initial Date FDA Received: 08/27/2019
• Supplement Dates Manufacturer Received: 08/09/2019
• Supplement Dates FDA Received: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other