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

Model Number 383517

Device Problem Missing Information (4053)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/20/2022

Event Type  malfunction  

Event Description

It was reported that the bd nexiva¿ closed iv catheter system experienced missing label information.The following information was provided by the initial reporter: upon product arrival, the customer noticed that there was no printed product information (size and cat#) or barcode on the shelf carton.

Manufacturer Narrative

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

Manufacturer Narrative

H6: investigation summary our quality engineer inspected the photographs submitted for evaluation.Bd received four photographs of 20ga x 1.25in.Nexiva single port units.Through the visual inspection of the provided photos, we discovered there is a pink and white blank label placed where the correct information should be.Your reported issue was confirmed.This was the physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect relating to an operator error in the packaging process.During packaging the label is printed and applied to the box of units.To mitigate the occurrence of a defect, a vision system inspects the label for legibility, barcode, lot, and date and rejects parts that are missing content.A device history record review showed no non-conformances associated with this issue during the production of this batch.

Event Description

It was reported that the bd nexiva¿ closed iv catheter system experienced missing label information.The following information was provided by the initial reporter: upon product arrival, the customer noticed that there was no printed product information (size and cat#) or barcode on the shelf carton.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVENOUS CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15635977
• MDR Text Key: 306786262
• Report Number: 1710034-2022-00608
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835172
• UDI-Public: 30382903835172
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 383517
• Device Catalogue Number: 383517
• Device Lot Number: 2048021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1