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

Catalog Number 383531

Device Problem Separation Failure (2547)

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

Event Date 12/07/2023

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 did not retract.The following information was provided by the initial reporter, translated from japanese to english: short description: needle safety mechanism does not work long description: the safety mechanism did not work when the needle was removed.

Manufacturer Narrative

Investigation results: the complaint that the safety mechanism did not work when the needle was removed was confirmed and the cause appeared to be manufacturing related.Tool wear, incorrect setup on changeover, operator handling, and insufficient product separation barrier may cause the bump to be out of specification (small or missing).Preventative maintenance and 100% vision, product separation barrier is performed to mitigate the occurrence of this defect.It is very unlikely that this occurred in the clinician environment.It takes a significant amount of force to remove the cannula from the tip shield.Most likely the bump is not within specification or nonexistent, causing the cannula to completely be removed and the washer to fall out.Four photographs and one 24ga nexiva unit from lot #3146707 were provided for investigation.The photographs and physical sample showed the cannula completely separated from the tip shield safety mechanism.The outside diameter of the needle was within specification; however, it appeared that needle was allowed to separate from the tip shield due to manufacturing defect.No other similar complaints were reported from this lot.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.

Event Description

No additional information.

• 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 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: 18456137
• MDR Text Key: 332729738
• Report Number: 1710034-2023-01507
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K102520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/29/2024

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: Other
• Device Catalogue Number: 383531
• Device Lot Number: 3146707
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 01/05/2024
• Supplement Dates Manufacturer Received: 01/29/2024
• Supplement Dates FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1