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

Model Number 383532

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 10/11/2021

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 2 bd nexiva¿ closed iv catheter system had reported of foreign matter.The following information was provided by the initial reporter, translated from (b)(6): "access port discoloration".

Manufacturer Narrative

H6: investigation summary : our quality engineer inspected the samples and photographs submitted for evaluation.Bd received two unopened units and four photographs for investigation.Through the visual/microscopic evaluation the septum of the q-sytes displayed a yellow tint or discoloration.There were no other anomalies or damage observed with the q-syte unit.The reported issue was confirmed.Although the reported issue was confirmed, we are unable to determine an exact root cause.Discoloration of the q-syte septum may be raw material related; however, no quality issues were found for the inspections of the raw material lots used in the q-syte production.During the q-syte manufacturing process discoloration of the septum may occur during the adhesive curing process if the part remains in the oven beyond a set time.There is an automated rejection set for the parts that are left in the oven beyond prescribed time period.Quality records have been consulted for tracking and trending purposes and this was the first occurrence of this failure mode.Sterilization of the device is not commonly associated with discoloration of the septum however there is a small likelihood that discoloration may occur.No quality issues or process deviations were found.During handling/storage of the product discoloration may occur.The storage conditions of the product may have resulted in discoloring of the septum as revealed by the possible uv light discoloration during manufacturing.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.A device history record was reviewed.

Event Description

It was reported 2 bd nexiva¿ closed iv catheter system had reported of foreign matter.The following information was provided by the initial reporter, translated from japanese: "access port discoloration".

• 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
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12788719
• MDR Text Key: 280601871
• Report Number: 1710034-2021-00971
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835325
• UDI-Public: 30382903835325
• 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: 11/12/2021

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: 10/31/2021
• Device Model Number: 383532
• Device Catalogue Number: 383532
• Device Lot Number: 8325685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2021
• Initial Date FDA Received: 11/10/2021
• Supplement Dates Manufacturer Received: 11/12/2021
• Supplement Dates FDA Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2018
• 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