MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA CLOSED IV CATHETER SYSTEM SINGLE PORT 22 GA 1.00 IN; INTRAVASCULAR CATHETER

Model Number 383512

Device Problems Device Markings/Labelling Problem (2911); Illegible Information (4050)

Patient Problem No Patient Involvement (2645)

Event Date 11/27/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that 4 bd nexiva¿ closed iv catheter system single port 22 ga 1.00 in had a smeared package and was missing label information.The following information was provided by the initial reporter: "the customer reported about defective printing on the package.".

Event Description

It was reported that 4 bd nexiva¿ closed iv catheter system ¿ single port 22 ga 1.00 in had a smeared package and was missing label information.The following information was provided by the initial reporter: "the customer reported about defective printing on the package.".

Manufacturer Narrative

Investigation summary our quality engineer inspected the photographs submitted for evaluation.Bd received three photos.A device history record review showed no non-conformances associated with this issue during the production of this batch.Through visual examination, the photos revealed that no print was present on the top webs of the four seal packages confirming your reported defect.This defect occurs during the packaging process of the top web printing.The most likely cause is a mechanical printer error.H3 other text : see h.10.

• Brand Name: BD NEXIVA CLOSED IV CATHETER SYSTEM SINGLE PORT 22 GA 1.00 IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 11072423
• MDR Text Key: 226049595
• Report Number: 1710034-2020-00827
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835127
• UDI-Public: 30382903835127
• Combination Product (y/n): N
• PMA/PMN Number: K102520
• 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: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2023
• Device Model Number: 383512
• Device Catalogue Number: 383512
• Device Lot Number: 0160212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/24/2020
• Supplement Dates Manufacturer Received: 01/06/2021
• Supplement Dates FDA Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1