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

Catalog Number	383647
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	09/24/2024
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 tubing ruptured.The following information was provided by the initial reporter: there was an incident last night in ed imaging where a bd nexiva cannula blew/ ripped apart during the ct scan, which caused vein extravasation.It blew apart at the extension set part of the cannula extravasation of contrast can cause complications to the patient.
Additional Manufacturer Narrative
Additional information received.See b.Annex f code updated.
Event or Problem Description
22-oct-2024: received an email response from complainant for information.In reference to dot point 1: the patient had soft tissue damage as the vein blew - this being the indication of a vein extravasation.It is where the content of contrast/n saline leaks into the surrounding tissues and form a raised lump.In reference to dot point 2: the clamp was unclamped.This is tested and ensured prior to scan.This also is supported by the vein extravasation.With this, the pressure the radiographer set for contrast injection may have breached the lines limit.In reference to dot point 3: see reference to dot point 1 as both come under the same category.With this incident contrast was also noted on the surface of the patients skin as well.In total: visual outside skin was noted with leaked contrast, and internal soft tissue damage (extravasation) in addition with the blown extension line as noted by the pictures and report.
Additional Manufacturer Narrative
Investigation results: the complaint of a ruptured extension tube was confirmed; however, the root cause could not be determined.Three photographs and one extension tube from a 20g nexiva device with the attached dual port luer adapter were provided for investigation.The winged catheter adapter and catheter tubing had been cut away and were not returned for investigation.Based on the reported use, the damage likely occurred during power injection; however, due to the condition of the returned sample, it could not be determined with certainty whether the damage originated during manufacturing or use of the device.No damage or defects associated with the manufacturing process could be confirmed on the returned sample.The complaint has been documented and will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.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: 20495635
• Report Number: 1710034-2024-01171
• Device Sequence Number: 3554213
• Product Code: FOZ
• UDI-Device Identifier: 00382903836475
• UDI-Public: (01)00382903836475
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/02/2024

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: 383647
• Device Lot Number: UNKNOWN
• 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: 09/25/2024
• Supplement Date Received by Manufacturer: Not provided; 12/02/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 11/03/2024; 12/03/2024
• 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