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

Catalog Number 383591

Device Problems Retraction Problem (1536); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 bd nexiva¿ closed iv catheter system upon retraction of the needle, it would not retract properly because the base of the needle was bent.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

H.6.Investigation summary: the device history report for lot number 8087940 was reviewed, no related abnormalities were found.Material number 383591 for lot v was manufactured in april/2018.This is the first instance of both failure modes for this lot number.According to the sampling plan applied for product performance, this lot was accepted and released, with no defects being noted during final assembly or in packaging visual inspections.Additionally a sample was provided for the purpose of aiding our quality engineer's investigation, the returned sample had a bent needle that resulted in the inability to retract the needle.Investigation conclusion: during the sample evaluation one of the failure modes reported was confirmed but no as manufacturing issue, due the definite cause could not be determined for this incident.Although it is possible for the damage to have occurred during the assembly process, no evidence was found to support manufacturing related issues for the defect.Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: b.2.Event attributed to: other d.8.Device single use?: no h.3.Device returned to manufacture: yes.

Event Description

It was reported that the bd nexiva¿ closed iv catheter system upon retraction of the needle, it would not retract properly because the base of the needle was bent.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

The following fields have been updated due to corrected information: it was reported that the bd nexiva¿ diffusics¿ closed iv catheter system upon retraction of the needle, it would not retract properly because the base of the needle was bent.There was no report of exposure, serious injury or medical intervention.Medical device brand name: bd nexiva¿ diffusics¿ closed iv catheter system.

Event Description

It was reported that the bd nexiva¿ diffusics¿ closed iv catheter system upon retraction of the needle, it would not retract properly because the base of the needle was bent.There was no report of exposure, serious injury or medical intervention.

• Brand Name: BD NEXIVA¿ DIFFUSICS¿ 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
• MDR Report Key: 7695260
• MDR Text Key: 114680336
• Report Number: 9610847-2018-00209
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835912
• UDI-Public: 30382903835912
• Combination Product (y/n): N
• PMA/PMN Number: K173354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 383591
• Device Lot Number: 8087940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Date Manufacturer Received: 06/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other