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

Catalog Number 383552

Device Problem Separation Failure (2547)

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

Event Date 03/06/2024

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 with maxzero needle would not disengage from catheter.The following information was provided by the initial reporter: i was asked to reach out to you in regards to an issue that we experienced with a nexiva 22g.It was reported as a staff injury as well as patient, as the patient had to be re-poked.The nurse maneuvered the iv to loosen prior to insertion then inserted the iv and the needle wouldn't retract.They had to remove the iv as they couldn't disconnect and poke the patient again.I have attached the iv and lot number below and have the video on my phone if needed.13 mar 2024 (b)(6) was the occurrence, only injury is the patient having to have an iv inserted for a second time.

Event Description

No additional information.

Manufacturer Narrative

Correction cancel mdr: the investigation confirms the issue as failure to decouple which is not mdr reportable.Investigation the complaint that the needle would not decouple from the catheter adapter was confirmed from the video that was provided for investigation.As the tip shield component would not separate from the 22g nexiva catheter, the complaint was confirmed and the cause appeared to be manufacturing related.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.The appropriate manufacturing personnel were notified of this complaint.

• Brand Name: BD NEXIVA WITH MAXZERO
• 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: 19020737
• MDR Text Key: 339335529
• Report Number: 1710034-2024-00271
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835522
• UDI-Public: (01)00382903835522
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

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: Health Professional
• Device Catalogue Number: 383552
• Device Lot Number: 3320122
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 04/18/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1