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

Catalog Number 383591

Device Problem Separation Failure (2547)

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

Event Date 11/29/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion a supplemental report will be filed.

Event Description

It was reported that bd nexiva safety shield did not function.The following information was provided by the initial reporter: photo available, sample was disposed buy may have representative samples from this lot to provide.Please inquire about photo and possible samples on ack letter follow up.No adverse events event date of 11/29/2023 reported issue: safety mechanism did not engage.

Manufacturer Narrative

Our quality engineer inspected the 1 photo submitted for evaluation.The reported issue of safety shield activation failure (catheter) was confirmed upon inspection of the sample photo.Analysis of the sample photo showed that the cannula was outside of the tip shield.From the photo it could be seen that the cannula was missing a bump needed to properly acuate the needle shield.Bd determined that the cause of the failure was related to our manufacturing process.Actions have been made to help prevent the recurrence of this failure mode.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.We regret any inconveniences this incident may have caused you and your facility.

Event Description

Materials#: 383591 batch#: 2356219.It was reported by the customer that safety mechanism did not engage.Verbatim: rcc received a complaint via phone.Pir attached.(b)(6).Material: 383591.Lot: 2356219.Photo available, sample was disposed buy may have representative samples from this lot to provide.Please inquire about photo and possible samples on ack letter follow up.No adverse events: event date of (b)(6) 2023.Reported issue: safety mechanism did not engage.

• 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): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales UT ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18438155
• MDR Text Key: 331828569
• Report Number: 1710034-2023-01496
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835912
• UDI-Public: (01)30382903835912
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/26/2024

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: 383591
• Device Lot Number: 2356219
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 01/03/2024
• Supplement Dates Manufacturer Received: 01/26/2024
• Supplement Dates FDA Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1