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

Catalog Number	383559
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd nexiva sp with maxzero leaked at the septum.The following information was provided by the initial reporter: a staff brought me this concern today where blood and saline started coming out of the nexiva iv where we retract the needle.I have circled this in the attached image.Have you seen or heard this before.I have not and this might just be a one-off, but this is high risk for exposure.Let me know your thoughts.29 oct: there was no adverse event or serious injury.The patient was stable, and any blood exposure did not come into contact with the clinical staff.
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.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: the complaint of a leak was confirmed and the cause appeared to be manufacturing related.One photograph and one 18g nexiva unit from lot 4156835 were provided for investigation.The cannister and septum were noted to be deformed within the catheter adapter, which likely created a fluid path that allowed fluid to leak.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.

• Brand Name: BD NEXIVA SP WITH MAXZERO
• 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: 20678468
• Report Number: 1710034-2024-01333
• Device Sequence Number: 8395868
• Product Code: FOZ
• UDI-Device Identifier: 00382903835591
• UDI-Public: (01)00382903835591(11)240604(17)270531(10)4156835
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 383559
• Device Lot Number: 4156835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 12/11/2024
• 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