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

Catalog Number 383532

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 11/21/2023

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 needle was slow to disengage.The following information was provided by the initial reporter: sluggish to separate needle from catheter.During use.Completes with more info after further contact with customer.27 nov 2023 additional information: could you please provide a date of event? not a specific date.It´s an experience and feeling they have had the last 6 months.Has there been any patient impact (serious injury, medical intervention, change of treatment required)? no.Has there been any healthcare worker¿s exposure to blood or bodily fluids? no.Have any other actions been taken? no.

Event Description

Sluggish to separate needle from catheter.During use.Completes with more info after further contact with customer.27 nov 2023 additional information: ¿ could you please provide the lot number of the defective product? lotnr 3178167.¿ could you please provide a date of event? not a specific date.It´s an experience and feeling they have had the last 6 months ¿ has there been any patient impact (serious injury, medical intervention, change of treatment required)? no ¿ has there been any healthcare worker¿s exposure to blood or bodily fluids? no ¿ have any other actions been taken? no ¿ please also provide us with the full pickup address, contact name and number, department name, floor number, and any additional details such as (pick up at reception, goods in yard, etc.) and we will schedule sample pick-up request for you using tnt carrier.(b)(6).¿ if it is not possible to return the physical sample, can you provide detailed photographs of the affected product? there are both used and not used samples available.

Manufacturer Narrative

Current control there is an in-process functional test and outgoing inspection in place to check for retraction and correct assembly (premature decouple, decouple failure, tip shield failure, crimp check).Retraction failure was not observed for both returned representative samples.The reported defect could not be confirmed.Dhr review also shows no abnormality during production and qa outgoing process.Hence, root cause could not be determined.Information will be captured on trend reports and monitored.

• 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): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18332268
• MDR Text Key: 330969030
• Report Number: 1710034-2023-01443
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835325
• UDI-Public: (01)30382903835325
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K102520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

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: 383532
• Device Lot Number: 3178167
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1