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

Catalog Number	38353
Medical Device Problem Code	Break (1069)
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
H3: a follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
It was reported that bd nexiva safety mechanism broken.The following information was provided by the initial reporter: inserted diffusics piv, when removing the wire, the needle and wire was removed but the grey shield normally attached to the needle and removed with it stayed attached to the iv.It was easily removed from the patient but instead of one piece being removed i ended up with three broken pieces (the needle, the cap, and a small metal piece that fell out when it broke).There has been no issue with the iv in the patient.Broken pieces were collected and provided to manager.
Additional Manufacturer Narrative
Investigation results: the complaint that the needle separated from the tip shield safety mechanism was confirmed; however, the root cause could not be determined.One needle and safety mechanism from a 24g nexiva device were provided for investigation.The needle was received separate from the tip shield.It was noted that the metal washer was missing from the tip shield safety mechanism and was not returned with the safety mechanism.The customer reported that a small metal piece fell out when the needle was disengaged.A functional test showed that the needle was crimped and would not pass through a representative metal washer.As the sample condition supports the complainant¿s description of the reported event, the complaint was confirmed; however, the root cause could not be determined since the metal washer was not returned with the safety mechanism.No other similar complaints were reported from the implicated 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.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: 21247073
• Report Number: 1710034-2025-00073
• Device Sequence Number: 3664195
• Product Code: FOZ
• UDI-Device Identifier: 00382903835300
• UDI-Public: (01)00382903835300(11)230111(17)251231(10)3011621
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2025

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 Expiration Date: 12/31/2025
• Device Catalogue Number: 38353
• Device Lot Number: 3011621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2025
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown