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

Catalog Number	383552
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported defect could not be refuted nor confirmed in the absence of a sample.The root cause cannot be determined for an unconfirmed defect.A complaint history (chr) review could not be performed as no batch/lot number was made available for this reported event.A device history record(dhr) review could not be performed as no batch/lot number was made available for this reported event.A review of the applicable fmea/eura (peura rm5796 rev26) indicates that the potential risk of the reported event was assessed appropriately in the risk management documentation.Complaints received for this device and reported condition will continue to be tracked and trended.
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: 1.First of all on insertion the ¿filter¿ when loosened/removed leaks blood as the coloured end blocks the nurses ability to see the blood coming to the end of the tubing.Also, depending on the flow back of blood sometimes we don¿t have time to ¿clamp¿ the tubing before blood gets to the very end.2.Another way nurses are getting exposure to blood from this product is through the iv caps.Once inserted, if blood was overfilled in the tubing it leaks around the luer lock and once flushed with saline or ivf, the blood leaks out from the bottom of the cap.I have also had blood leak from the top portion of the cap both on insertion of ivf/sl and after removing sl.3.I have a third way seen blood exposure to nurses from the blunt end, where the grey/white hub gets removed after insertion.This iv product has multiple blood exposure and is a very poor design.I will be submitting another psls after getting blood on my hands after giving iv sedation and flushing with saline from the bottom of the cap.This happens multiple cases a day, and i am not the only one who experiences this issue.Blood exposure from ivs is completely unnecessary and unsafe.

• 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: 20510851
• Report Number: 1710034-2024-01189
• Device Sequence Number: 7044574
• Product Code: FOZ
• UDI-Device Identifier: 00382903835522
• UDI-Public: (01)00382903835522
• 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
• Report Date (Section B): 10/08/2024

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: 383552
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown