MAUDE Adverse Event Report: BECTON DICKINSON NEXIVA; INTRAVASCULAR CATHETER

Catalog Number	383516
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd nexiva 20 ga x 1 in single port leaked.It was reported by customer that proper insertion procedure was performed and iv inserted into patient to left ac [antecubital] with lab draw.While obtaining labs, port located below catheter was leaking blood.Flushed iv catheter and fluids were also leaking at same site.Attempted to troubleshoot connections of iv but catheter continued to leak; iv removed from patient intact.Rcc received a complaint via email.Proper insertion procedure was performed and iv inserted into patient to left ac [antecubital] with lab draw.While obtaining labs, port located below catheter was leaking blood.Flushed iv catheter and fluids were also leaking at same site.Attempted to troubleshoot connections of iv but catheter continued to leak; iv removed from patient intact.Demonstrated issue with charge nurse by flushing removed iv catheter and compared to another product of the same lot number that did not have this issue.Patient had to have another iv inserted due to first iv malfunction.No issues with new iv established with same lot number and no other issues with catheter during shift.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.B3.The date received by manufacturer has been used for this field.
Additional Manufacturer Narrative
No photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.

• Brand Name: NEXIVA
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23778634
• Report Number: 2243072-2025-01471
• Device Sequence Number: 10345507
• Product Code: FOZ
• UDI-Device Identifier: 00382903835164
• UDI-Public: (01)00382903835164(11)250712(17)280630(10)5187211
• 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: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2026

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: 383516
• Device Lot Number: 5187211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American