MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. NEXIVA DUAL PORT WITH Q-SYTE, 20G X 1.25"; INTRAVASCULAR CATHETER

Model Number 383537

Device Problem Missing Information (4053)

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

Event Date 03/21/2022

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.

Event Description

It was reported while using nexiva dual port with q-syte, 20g x 1.25" the label was missing.The following information was provided by the initial reporter: one out of 4 boxes in the case, was send without labels.

Event Description

It was reported while using nexiva dual port with q-syte, 20g x 1.25" the label was missing.The following information was provided by the initial reporter: one out of 4 boxes in the case, was send without labels.

Manufacturer Narrative

H.6.Investigation: our quality engineer inspected the photograph submitted for evaluation.Bd received one photograph which displayed the dispenser box label missing.The reported issue was confirmed.This was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect relating to the packaging process.A missing dispenser box label may occur during the packaging process due to incorrect setup/jam or during manual labeling due to operator error.Periodic inspections and setup are performed per the quality plan as well as operator training for the packaging process.Preventative maintenance (pm) is also performed to ensure proper functioning of the equipment during the automated labeling process.The pm records were reviewed and verified as up to date during the manufacturing of this lot.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• Brand Name: NEXIVA DUAL PORT WITH Q-SYTE, 20G X 1.25"
• Type of Device: INTRAVASCULAR 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: 14073371
• MDR Text Key: 289012469
• Report Number: 1710034-2022-00178
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835370
• UDI-Public: 30382903835370
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 383537
• Device Catalogue Number: 383537
• Device Lot Number: 1298357
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2021
• 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