MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA; INTRAVASCULAR CATHETER

Catalog Number CVMP-BD NEXIVA-2023

Device Problem Separation Problem (4043)

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

Event Date 12/15/2023

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 needle did not retract.It was reported that clinician and/or any patients have encountered difficulty threading, dull needle, difficult to insert, and needle did not retract.Verbatim: clinician experienced: difficulty threading.Dull needle.Difficult to insert.Needle did not retract.-it is difficult to insert on tough skin-i feel like the needle is dull- i've had a few difficult to insert initially.Also, i had 2 times where the needle did not come out completely and i had to ask another rn to assist me to pull the needle completely out once i got blood return.Otherwise, i like the tubing/occluding it to get labs, it is a very clean process.But i do prefer the old ones for insertion better.Please see attached excel sheet for additional information.

• Brand Name: BD NEXIVA
• 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): 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: 18460750
• MDR Text Key: 332734403
• Report Number: 9610847-2023-00362
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/19/2023

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: Health Professional
• Device Catalogue Number: CVMP-BD NEXIVA-2023
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1