MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA SINGLE PORT WITH MAXZERO, 22G X 1.0"; INTRAVASCULAR CATHETER

Catalog Number 383552

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 08/11/2022

Event Type  malfunction  

Event Description

It was reported while using bd nexiva single port with maxzero, 22g x 1.0" the safety mechanism would not disengage.There was no report of patient impact.The following information was provided by the initial reporter: material no: 383552, batch no: 2122512.It was reported by customer that "the grey and white piece would not disengage off the septum piece." single port was used for demo purposes.During the demo, the bd nurse in-servicing, the grey and white piece would not disengage off the septum piece.

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval: yes.D.9.Returned to manufacturer on: 06-sep-2022.H.6.Investigation summary: our quality engineer inspected the sample and photographs submitted for evaluation.Bd received one opened 22g x 1.00in nexiva device from lot number 2122512.In addition, two photographs were submitted which displayed the unit with a pulled needle in the safety shield with the catheter adapter still attached to the tip shield.Through the visual inspection of the sample returned, no visible defects were observed.The unit was then reengaged and retracted to try to recreate the reported issue.Through our testing a full retraction was observed, and the catheter adapter decoupled from the tip shield after several trials.Further evaluation of all the parts displayed adhesive present on the catheter adapter and the tip shield.The reported issue was confirmed.This was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect relating to excessive adhesive being dispensed.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported while using bd nexiva single port with maxzero, 22g x 1.0" the safety mechanism would not disengage.There was no report of patient impact.The following information was provided by the initial reporter: material no: 383552.Batch no: 2122512.It was reported by customer that "the grey and white piece would not disengage off the septum piece." , single port was used for demo purposes.During the demo, the bd nurse in-servicing , the grey and white piece would not disengage off the septum piece.

• Brand Name: BD NEXIVA SINGLE PORT WITH MAXZERO, 22G X 1.0"
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15351713
• MDR Text Key: 305638179
• Report Number: 9610847-2022-00339
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835522
• UDI-Public: 00382903835522
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170336
• 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: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 383552
• Device Lot Number: 2122512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2022
• Initial Date FDA Received: 09/02/2022
• Supplement Dates Manufacturer Received: 10/06/2022
• Supplement Dates FDA Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2022
• 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