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

Catalog Number 383536

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

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

Event Date 04/02/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A sample is not available for evaluation.However, a no sample investigation and device history record review will be completed.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the cap/plug on a bd nexiva¿ closed iv catheter system w/ dual port was loose or completely disconnected causing leakage of blood during use.There was no report of injury or medical interventions.

Manufacturer Narrative

Investigation summary: no sample was received for testing or evaluation.The customer's experience could not be confirmed.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 7347569.Investigation conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM W/ DUAL PORT
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7434810
• MDR Text Key: 105697142
• Report Number: 1710034-2018-00170
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835363
• UDI-Public: 30382903835363
• Combination Product (y/n): N
• PMA/PMN Number: K161777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 383536
• Device Lot Number: 7347569
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other