MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA HF Y W/CAP; PERIPHERAL IV CATHETERS

Catalog Number	383646
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	12/19/2024
Type of Reportable Event	Serious Injury
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 hf y w/cap air embolism reported.The following information was provided by the initial reporter: air embolism during ct scan while using bd nexiva.Air column was noticed during the scan review 21-dec-2024 - received an email response from complainant for information requested.1.Provide the event occurrence date.Ans: 19/12 2.Provide the lot number ans: unknown.Cannula was set in the general ward and went down to radiology for a scan where the issue occur customer response (b)(6) 2025 was air noted in the nexiva tubing? ans : no , do take note that patient was undergoing ct scan , high flow.Was air noted in the iv tubing? ans : no , do take note that patient was undergoing ct scan , high flow.Was there any damage evident to the nexiva? ans : no , but q-syte was not replaced during power injection.Have already informed the hospital on the need to remove q-syte before power injection.
Additional Manufacturer Narrative
Investigation results: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of product malfunction during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.
Event or Problem Description
No additional information.

• Brand Name: BD NEXIVA HF Y W/CAP
• 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: 21131438
• Report Number: 1710034-2024-01597
• Device Sequence Number: 6825159
• Product Code: FOZ
• UDI-Device Identifier: 00382903836468
• UDI-Public: (01)00382903836468
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 383646
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 01/27/2025
• 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
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown