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

Catalog Number 383536

Device Problem Leak/Splash (1354)

Patient Problem Exposure to Body Fluids (1745)

Event Date 03/16/2024

Event Type  Injury  

Event Description

It was reported that bd nexiva dual port squirted blood and saline out of second port.The following information was provided by the initial reporter: on (b)(6) 2024 a nurse went to flush a nexiva 20g dual port, the catheter line was full of blood and when the nurse flushed the main port the secondary port squirted blood and the saline flush out and into the rn's eye.This is concerning for staff safety but also patient risk for infection if the injection ports are not occlusive.

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 and material number was made available for this reported event.A device history record(dhr) review could not be performed as no batch/lot and material number was made available for this reported event.A review of the applicable fmea/eura (afmea rm5769 rev (27(aa)) 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 Description

No additional information.

Manufacturer Narrative

Investigation results: our quality engineer inspected the representative samples submitted for evaluation.Bd received two 20gx1.00in nexiva devices from lot number 2088292.A device history record review showed no non-conformances associated with this issue during the production of this batch.The initial report received did not provide a lot number.A gross visual inspection shows that the units are sealed in their packaging and there are no observed defects.The two units were removed from their packaging and the needle was decoupled from the tip shield.The catheter assembly was used for testing.A luer lock syringe was used to flush water through the primary port while the second port was connected to a q-syte and no leakage was observed.The same activity was repeated, this time flushing from the secondary port and closing the first port and no leakage was observed.The returned units provided for evaluation met and performed per the required manufacturing specifications.There was no physical/mechanical evidence to confirm and support a manufacturing process related issue for the failures stated in your report.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.

• Brand Name: BD NEXIVA DUAL PORT
• Type of Device: PERIPHERAL IV CATHETER
• 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: 19074201
• MDR Text Key: 339773565
• Report Number: 1710034-2024-00307
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835362
• UDI-Public: (01)00382903835362
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 383536
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention