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
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd nexiva diffusics 20g x 1.25 in tubing separated from the adaptor the following information was provided by the initial reporter: it was reported by the customer that bd nexiva diffusics 20 ga x 1.25 in closed iv catheter system.The pre-attached extension tubing dislodged from the stabilization platform after starting the iv on the patient.The caregiver was able to tamponed the vein and remove the catheter assembly with only a few cc blood loss.Verbatim: rcc received a complaint via email.Bd nexiva diffusics 20 ga x 1.25 in closed iv catheter system.The pre-attached extension tubing dislodged from the stabilization platform after starting the iv on the patient.The caregiver was able to tamponed the vein and remove the catheter assembly with only a few cc blood loss.Additional info: 1.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.The pre-attached extension tubing dislodged from the stabilization platform after starting the iv on the patient.Caregiver was able to tamponed the vein and remove the catheter assembly with only a few cc blood loss.2.Can you please provide an exact date of event in format dd-mmm-yyyy? (b)(6) 2024.3.Total number of occurrences? one for this event.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
This mdr submission is a duplicate of this mdr pr (b)(4), hence this mdr pr #(b)(4) will be cancelled.

• Brand Name: BD NEXIVA DIFFUSICS 20G X 1.25 IN
• Common Device Name: 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): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20869163
• Report Number: 9610847-2024-00367
• Device Sequence Number: 8564954
• Product Code: FOZ
• UDI-Device Identifier: 00382903835935
• UDI-Public: (01)00382903835935(11)240513(17)270430(10)2356441
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K173354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 383593
• Device Lot Number: 4124921
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown