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

Catalog Number 383536

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2022

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

It was reported that the bd nexiva¿ dual port closed iv catheter systems safety mechanism failed to disengage during use.This occurred with 2 catheters, and this complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: safety mechanism malfunctioned.2 incidents from same lot number on same item number when safety malfunctioned.One of the event dates is 9/30 & one is 9/29.

Event Description

It was reported that the bd nexiva¿ dual port closed iv catheter systems safety mechanism failed to disengage during use.This occurred with 2 catheters, and this complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "safety mechanism malfunctioned.2 incidents from same lot number on same item number when safety malfunctioned.One of the event dates is 9/30 & one is 9/29.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 25-oct-2022.H6: investigation summary: our quality engineer inspected the samples submitted for evaluation.The complaint that the safety mechanism malfunctioned could not be confirmed from an analysis of the returned samples.Twenty-one sealed 20g nexiva devices and one shielded needle from lot #2202381 were returned for investigation.The needle from the used sample had been retracted and locked within the tip shield.The used nexiva device was not fully returned for investigation; therefore, it could not be determined if the catheter or adapter contributed to the reported malfunction.A functional test of the sealed units revealed nothing remarkable.No defects or potential contributing factors of the reported event were identified on the returned samples.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• Brand Name: BD NEXIVA¿ DUAL PORT 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
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15682398
• MDR Text Key: 303173841
• Report Number: 1710034-2022-00628
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835362
• UDI-Public: (01)00382903835362
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383536
• Device Lot Number: 2202381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2022
• 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