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

Catalog Number 383512

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that 3 bd nexiva¿ closed iv catheter systems experienced no label or missing label information.The following information was provided by the initial reporter: the customer reported about improper printing on the package.

Event Description

It was reported that 3 bd nexiva¿ closed iv catheter systems experienced no label or missing label information.The following information was provided by the initial reporter: the customer reported about improper printing on the package.

Manufacturer Narrative

H6: investigation summary: bd received two photographs which displayed missing print on the unit label.Your reported issue was confirmed as the photographs observed displayed that the packages contained missing print on the unit label.Based on the observations made during the investigation, there are two contributing factors that may have occurred during the manufacturing process.The missing print is likely due to the top web splice when a new roll of top web is connected to the end of the current roll.This could result in an operator error as the operator is to sort through the rejected parts and hand pack the dispenser with the approved parts.The other situation that may take place in the manufacturing process can occur due to a clogged/damaged print head, printer failure or software issue.Parts with missing print from these potential causes can be automatically packaged into dispenser boxes.A clogged or damaged printhead is unlikely to result in completely blank units: some text would likely be printed.A software issue or a printer failure is likely to result in completely blank top web label.A corrective action project #scm-333 has been initiated to implement a vision inspection system that will inspect top web label for missing print.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• 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: 11168008
• MDR Text Key: 227069342
• Report Number: 1710034-2021-00024
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835126
• UDI-Public: 00382903835126
• Combination Product (y/n): N
• PMA/PMN Number: K183399
• 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: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 383512
• Device Lot Number: 0160212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Date Manufacturer Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1