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

Catalog Number	383511
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2025
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.B3.The date received by manufacturer has been used for this field.E1.Address information was not provided, therefore, xx was used as a place holder.
Event or Problem Description
It was reported that bd nexiva single port unable to disengage needle.The following information was provided by the initial reporter: "event: when starting and iv line on patient, line was accessed with positive blood return and catheter advanced.Once nurse went to retract needle, needle would not retract and was stuck causing the active iv line to be lost on patient.A second attempt was made starting an iv line in a different location and positive blood return was noted and catheter was advanced.Nurse attempted to retract needle again and was yet again stuck.It took multiple people and attempts to get the needle to retract from iv." on (b)(6) 2025 well, a complication was the needle not retracting, causing a good line to be lost and the patient having to be stuck again.The patient was not happy so that is a negative outcome.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: a device history record review was completed by our quality engineer team for provided material number 383511 and lot number 4276197.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.

• Brand Name: BD NEXIVA SINGLE PORT
• 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: 21233595
• Report Number: 1710034-2025-00060
• Device Sequence Number: 8602710
• Product Code: FOZ
• UDI-Device Identifier: 00382903835119
• UDI-Public: (01)00382903835119(11)241002(17)270930(10)4276197
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2025

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: 383511
• Device Lot Number: 4276197
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown