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

Catalog Number	383540
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	01/17/2025
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 leaked at the septum when the needle was removed.The following information was provided by the initial reporter: after removing the stellate they experience the blood leakage from self sealing septum hub of nexiva in 4 cases.I couldn't collect the effected sample but i have collected same batch new sample.The good vain has damages reported by nurse.
Event or Problem Description
(b)(6) 2025 it is stated that there was blood exposure to the health care provider.1.Was the healthcare provider wearing gloves/personal protective equipment? ans: yes, hcp was wearing gloves but no ppe.2.Was there any serious injury to the health care worker (required diagnostics, or medical treatment other than basic care)? ans: no, only blood exposure on gloves.
Additional Manufacturer Narrative
See b.
Additional Manufacturer Narrative
Investigation results: a device history record review was completed by our quality engineer team for provided material number 383540 and lot number 4093440.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.
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: 21317693
• Report Number: 1710034-2025-00126
• Device Sequence Number: 15420259
• Product Code: FOZ
• UDI-Device Identifier: 00382903835379
• UDI-Public: (01)00382903835379(11)240731(17)270731(10)4207279
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 02/27/2025

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: Other
• Device Catalogue Number: 383540
• Device Lot Number: 4093440
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: Not provided; 02/27/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 02/12/2025; 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown