MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 20 G X 1 IN. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383556

Device Problems Fail-Safe Design Failure (1222); Device Operates Differently Than Expected (2913)

Patient Problem Needle Stick/Puncture (2462)

Event Date 09/26/2017

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 the safety mechanism on a 20 g x 1 in.Bd nexiva¿ closed iv catheter system failed to function properly, leaving the needle exposed.This resulted in a clean needle stick and there was no report of medical interventions.

Manufacturer Narrative

Investigation: according the customer information the sample received was analyzed visual and functionally and it did not show any issue at moment of attempting remove the cannula from the tip shield component, once that the cannula was removed from the back of the septum this keep into the tip shield without move out of this, this sample show a good safety shield activation.Please see attached photos in the additional information section.Complaint trending review for this lot# 7068505 related to this issue reveals 1st complaint for this failure mode, previously 7 complains per safety shield activation has been reveal before, all of them were confirmed as a manufacturing issue.During the dhr review was not detected issues related to safety shield activation, the lot 7068505 was manufactured on march 2017 and no qn related to this lot was documented, no issues related to our q.A tech control plan that could help this issue to occur was detected.Manufacturing review: as part of our manufacturing process a linear torque arm was installed in order to avoid cannula hits, this station was updated also as an ergonomic improve help us to mitigate this failure mode.This quality issue has previously reviewed but some of them have been classified as not confirmed to the manufacturing process.Base on the parent evaluation s1 and low occurrence concludes no further action is required at this time.We will continue to monitor for trends.Bd was unable to duplicate or confirm the customer¿s indicated failure mode because the defect was not evident in the visual and functional inspection of the returned sample.We could not confirm a specific root cause for this issue since the actual sample received didn¿t show any issue related to the incident reported.

Manufacturer Narrative

The date of event was provided after mdr was submitted.Date of event updated to (b)(6) 2017.

• Brand Name: 20 G X 1 IN. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• 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
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6984144
• MDR Text Key: 91214686
• Report Number: 9610847-2017-00124
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835560
• UDI-Public: 00382903835560
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K161777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 383556
• Device Lot Number: 7068505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2017
• 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): Other