MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA DIFFUSICS 20G X 1.25 IN; INTRAVASCULAR CATHETER

Catalog Number 383593

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

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

Event Date 12/11/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd nexiva diffusics 20g x 1.25 in had foreign matter the following information was provided by the initial reporter: it was reported by the customer that the catheters had an unknown substance on them.Verbatim: rcc received a complaint via email.Email(s) attached.Sales rep xxxxx xxxxx reported that on po 662a40810, material# 383593.4 individual catheters had an unknown substance on them.

Manufacturer Narrative

Additional lot numbers provided: 3227705 and 3075960.

• Brand Name: BD NEXIVA DIFFUSICS 20G X 1.25 IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• 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: 18385637
• MDR Text Key: 331500880
• Report Number: 9610847-2023-00356
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835936
• UDI-Public: (01)30382903835936
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2024

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: 383593
• Device Lot Number: 3166691
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 11/30/2023
• Supplement Dates FDA Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/05/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1