MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. NEXIVA DIFFUSICS 20G X 1.25 IN; INTRAVASCULAR CATHETER

Catalog Number	383593
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the nexiva diffusics 20g x 1.25 in connector came apart from the tubing during use while inserting the catheter.The following information was provided by the initial reporter: "nurse was inserting the iv catheter and entire end/connector of the catheter came apart form the tubing.".
Additional Manufacturer Narrative
Investigation summary: a device history review was conducted for lot number 9031584.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 our quality engineers evaluation found the submitted device to have a proper application of adhesive to the tubing-adapter- junction.Although our team was unable to identify any abnormalities in the adhesive application it is currently believed that an inadequate amount of adhesive was applied to the tubing-adapter- junction which resulted in a weaker than expected bond.The most likely root cause for such an event is improper set up of the manufacturing equipment.To address this issue our facility has issued a quality alert to the production staff.
Event or Problem Description
It was reported that the nexiva diffusics 20g x 1.25 in connector came apart from the tubing during use while inserting the catheter.The following information was provided by the initial reporter: "nurse was inserting the iv catheter and entire end/connector of the catheter came apart form the tubing.".

• Brand Name: NEXIVA DIFFUSICS 20G X 1.25 IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 8961612
• Report Number: 9610847-2019-00550
• Device Sequence Number: 2559872
• Product Code: FOZ
• UDI-Device Identifier: 30382903835936
• UDI-Public: 30382903835936
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K173354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 383593
• Device Lot Number: 9031584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Initial Date Received by Manufacturer: 08/15/2019
• Supplement Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 09/04/2019
• Supplement Report FDA Received Date: 10/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other