MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA DUAL PORT Q-SYTE; PERIPHERAL IV CATHETERS

Catalog Number	383538
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	06/10/2024
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.
Event or Problem Description
It was reported that bd nexiva dual port q-syte tubing ballooned.The following information was provided by the initial reporter: our system is not letting me access the safety file, but basically we had a nexia 20g iv that swelled when flushed, which obviously cause the patient quite a bit of pain.Hard to flush, swelling in patients arm.
Additional Manufacturer Narrative
Investigation results: the complaint that the extension tubing swelled when flushed was confirmed and the cause may have been associated with use of the device.One 20g nexiva device was received with two open unit packages from lot #3354890.The returned device exhibited evidence of use.The extension tubing was ballooned and expanded adjacent to the catheter adapter.The lumen of the iv catheter was patent to infusion and no occlusions or leaks were detected during functional testing.The wall thickness was found to be within specification.This type of damage can occur due to over-pressurization.The instructions for use (ifu) indicates that the maximum power injector pressure limit setting is 300 psi.No damage or defects associated with the manufacturing process or raw materials that could cause or contribute to the reported issue were identified from the sample analysis.A review of the inspection records and quality/manufacturing controls for the implicated lot indicated no issues with the manufacturing process.No other similar complaints have been reported from the implicated lot.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 DUAL PORT Q-SYTE
• 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: 19705613
• Report Number: 1710034-2024-00698
• Device Sequence Number: 18089089
• Product Code: FOZ
• UDI-Device Identifier: 00382903835386
• UDI-Public: (01)00382903835386
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2024

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: 383538
• Device Lot Number: 3354890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown