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

Catalog Number	383531
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd nexiva 24ga 0.75in y 'cap' fell off.The following information was provided by the initial reporter: concern description: regularly stocked iv system we use island health wide for years.The attached caps always come loose and not fully tightened, is there anyway for the manufacturer to full tight pre attached cap? date of incident: (b)(6) 2024.Concern description: regularly stocked iv system we use island health wide for years.The attached caps always come loose and not fully tightened, is there anyway for the manufacturer to full tight pre-attached cap? no adverse event reported.I have no updates.In the product complaint i explain very clearly the attached y-site cap for the nexiva iv¿s is only partially tightened when removed from the packaging.This cap fell off for a nurse when they were inserting an iv into a patient, and had they not noticed the patient would have bled extensively from the open port.This has happened multiple times at our site to different nurses, and in all my time of using the nexiva iv¿s has been an issue since they were rolled out.My staff were just wondering if it was possible for the pre-attached y-site cap to come properly tightened inside manufacturer packaging to prevent this error in future.Additional info: based on the photo you shared the ¿loose¿ cap is the one that comes pre-attached to the nexiva iv in the package.Not the one that comes separate and needs to be attached by staff when they insert the iv.Not sure what to call that pre-attached cap?.
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Additional Manufacturer Narrative
Investigation results: a device history record review was completed by our quality engineer team for provided material number 383531 and lot number 4120704.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Becton dickinson and company's (bd) medication delivery solutions (mds) business unit will discontinue malfunction mdr reporting for certain device failures that have not caused or contributed to deaths or serious injuries in the past two years, and where the likelihood of a death or serious injury as a result of these malfunctions is remote.This decision follows fda guidelines (medical device reporting for manufacturers guidance for industry and food and drug administration staff issued nov 8, 2016, reference section 2.15).Bd notified fda of this decision on mar 3, 2025.Fda has reviewed and responded to bd¿s notification (reference fda document # (b)(4)) on march 7, 2025.This documentation is available in bd document management system (sap) as dir (b)(4).This supplemental mdr is being filed to document that the below device failure will no longer be considered a reportable malfunction mdr for the product family below: product family: nexiva.Device failure: cap / shield loose / off.
Event or Problem Description
No additional information.

• Brand Name: BD NEXIVA
• Common Device Name: 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: 20440296
• Report Number: 1710034-2024-01141
• Device Sequence Number: 18183617
• Product Code: FOZ
• UDI-Device Identifier: 00382903835317
• UDI-Public: (01)00382903835317(11)240429(17)270430(10)4120704
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/01/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 383531
• Device Lot Number: 4120704
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: 10/22/2024; 05/01/2025
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 10/23/2024; 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown