MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA¿ DIFFUSICS¿ 24G X 0.75 IN GLOBAL; INTRAVASCULAR CATHETER

Catalog Number 383691

Device Problem Mechanical Problem (1384)

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

Event Date 04/25/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 safety mechanism failed and breaks during use with a bd nexiva¿ diffusics¿ 24g x 0.75 in global.The following information was provided by the initial reporter: successfully inserted the cannula into the patients vein.While activating the safety device and removing the needle the needle became detached from the safety gray colored casing, which remained attached to the back end of the cannula.Disposed the needle into the sharps bin.Detached the gray colored part of the device from the back end of the cannula and noticed that there was a small piece of metal lying on the patients skin.We kept the gray colored piece and the piece of metal for return.The cannula itself, in the patients vein was ok for use, however there was a failure with the safety mechanism in this incident.

Manufacturer Narrative

Investigation: a device history review was conducted for lot number 814838.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally the sample submitted by your facility was investigated by our quality engineers.During their evaluation they noted that the needle for this device was missing.Unfortunately without this component, the root cause for this complaint could not be determined at the conclusion of our review.

Event Description

It was reported that safety mechanism failed and breaks during use with a bd nexiva¿ diffusics¿ 24g x 0.75 in global.The following information was provided by the initial reporter: successfully inserted the cannula into the patients vein.While activating the safety device and removing the needle the needle became detached from the safety gray colored casing, which remained attached to the back end of the cannula.Disposed the needle into the sharps bin.Detached the gray colored part of the device from the back end of the cannula and noticed that there was a small piece of metal lying on the patients skin.We kept the gray colored piece and the piece of metal for return.The cannula itself, in the patients vein was ok for use, however there was a failure with the safety mechanism in this incident.

• Brand Name: BD NEXIVA¿ DIFFUSICS¿ 24G X 0.75 IN GLOBAL
• 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
• MDR Report Key: 8601245
• MDR Text Key: 145947910
• Report Number: 9610847-2019-00368
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K173354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 383691
• Device Lot Number: 8148838
• Date Manufacturer Received: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other