MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA; PERIPHERAL IV CATHETERS

Catalog Number 383511

Device Problems Particulates (1451); Device Contamination with Chemical or Other Material (2944)

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

Event Date 02/28/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

Event Description

It was reported that bd nexiva has foreign matter on its tip.The following information was provided by the initial reporter, translated from chinese to english: the tip of the catheter is burred and not smooth, the safety protection device is too tight to start properly, there are burrs on the catheter wall, and there are black spots on the catheter wall.

Manufacturer Narrative

Additional lot numbers were provided in this complaint for material number 383511.Lot # 3087425; mnf date 29 mar 2023; exp date 31 mar 2026.Lot # 3040439; mnf date 14 feb 2023; exp date 31 jan 2026.

Manufacturer Narrative

Internal record review conducted.Aware date for this complaint has been corrected to reflect (b)(6) 2024.

Manufacturer Narrative

Investigation results: a device history record review was completed by our quality engineer team for provided material number 383511 and lot number 3040439, 3087425, 2045799.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

Event Description

No additional information.

• Brand Name: BD NEXIVA
• Type of Device: PERIPHERAL IV CATHETERS
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18993582
• MDR Text Key: 339206575
• Report Number: 1710034-2024-00252
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835119
• UDI-Public: (01)00382903835119
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/10/2024

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 Catalogue Number: 383511
• Device Lot Number: 3087425
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: 02/29/2024; 03/04/2024; 06/10/2024
• Supplement Dates FDA Received: 03/29/2024; 04/16/2024; 06/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1