MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Model Number 383532

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 09/24/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that 8 bd nexiva¿ closed iv catheter systems had no label on their outer packaging units.This was noticed prior to use.The following information was provided by the initial reporter: "received another bd iv cath with no printing on the outer packaging of the actual product per the attached picture.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2020-10-28.H6: investigation summary our quality engineer inspected the samples and photograph submitted for evaluation.Bd received eight sealed packages from ref.383532 and one photo.A device history record review could not be performed as the lot number is unknown.During the visual examination it was observed that print was missing confirming the reported issue.When a new roll of top web is replaced, missing print can occur.These units are automatically rejected but still have the potential to be hand packed when an operator sorts through the rejected parts.Missing print can also occur due to printer failure or a software issue.Although the specific root cause was not determined, corrective actions are taking place to address the potential root causes.

Event Description

It was reported that 8 bd nexiva¿ closed iv catheter systems had no label on their outer packaging units.This was noticed prior to use.The following information was provided by the initial reporter: "received another bd iv cath with no printing on the outer packaging of the actual product per the attached picture.".

• Brand Name: BD NEXIVA CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 10688092
• MDR Text Key: 214794492
• Report Number: 1710034-2020-00665
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835325
• UDI-Public: 30382903835325
• Combination Product (y/n): N
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 383532
• Device Catalogue Number: 383532
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other