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

Catalog Number	383539
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
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.Filing as malfunction at this time, it is unclear if si occurred.Additional information requested from the customer.
Event or Problem Description
It was reported that bd nexiva leaked.The following information was provided by the initial reporter: nexiva leaked from flash chamber after retraction (b)(6) 2024: hi, the information you have requested is as follows- the nurse had to stick a patient 3 different times, all 3 as soon as she got the cath inserted blood shot out all over the place.The impact on the patient and patient care from this incident was the patient at that point wouldn't allow the nurse to try again.So, the patient didn't receive the iv fluids the doctor ordered is my understanding.I do have one of the actual caths that was used sealed in a bio-bag in case it was needed for inspection.Thanks for your help on this matter.
Additional Manufacturer Narrative
Investigation results: the complaint of a leak was confirmed due to the circumstantial evidence that was observed on the returned sample and the cause appeared to be manufacturing related.One 18g nexiva unit from lot 4156834 was provided for investigation.The septum was misaligned within the catheter adapter, which could allow fluid to leak during use.What appeared to be blood residue was observed between the canister and the catheter adapter.A trend was identified for the reported failure and corrective actions have been implemented to investigate this type of incident and identify the root cause.The appropriate manufacturing personnel were notified of this complaint.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.
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: 21091901
• Report Number: 1710034-2024-01583
• Device Sequence Number: 8721667
• Product Code: FOZ
• UDI-Device Identifier: 00382903835393
• UDI-Public: (01)00382903835393(11)240604(17)270531(10)4156834
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2025

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: 383539
• Device Lot Number: 4156834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown