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

Catalog Number 383687

Device Problems Loose or Intermittent Connection (1371); Material Separation (1562)

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

Event Date 02/25/2019

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 tubing came loose and separated from the adapter during use.As reported by the customer, "update 27/2: nurse discover that the tube is lose from the external pink plastic piece that holds the tree way stopcock.She say it look just like the tube loosen from the pink piece.No cut or sight of external force or violence.Patient haven't done anything.They have tried to pull apart other nexiva without success.Product is destroyed by costumer.And no photos taken.No product left from same lot.They can't say exact date of event, in february 2019.".

Manufacturer Narrative

H.6.Investigation summary: a device history review was conducted for lot number 8086582.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.Unfortunately a sample could not be obtained for evaluation and testing.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.Without defective sample or photo it is difficult to perform the evaluation and determine the root of cause, for this reason we were not able to associate the reported defect to the mfg.Process.

Event Description

It was reported that the bd nexiva¿ closed iv catheter system tubing came loose and separated from the adapter during use.As reported by the customer, "update 27/2: nurse discover that the tube is lose from the external pink plastic piece that holds the tree way stopcock.She say it look just like the tube loosen from the pink piece.No cut or sight of external force or violence.Patient haven't done anything.They have tried to pull apart other nexiva without success.Product is destroyed by costumer.And no photos taken.No product left from same lot.They can't say exact date of event, in (b)(6) 2019.".

• Brand Name: 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
• MDR Report Key: 8418348
• MDR Text Key: 139191491
• Report Number: 9610847-2019-00217
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K161777
• 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: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 383687
• Device Lot Number: 8086582
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other