MAUDE Adverse Event Report: BECTON DICKINSON BD NEXIVA 20 GA X 1-1/4 IN SINGLE PORT; INTRAVASCULAR CATHETER

Catalog Number	383517
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd nexiva 20 ga x 1-1/4 in single port leaked complaint to the same phenomenon: the vent plug was not connected to the extension tube of the bd nexiva single port.When the user opened the steril packaging she saw that the vent plug was not connected to the luer adapter.It lay seperately in the steril packaging, see the attached photography.In a few more cases the user didn't notice this and inserted the catheter into the patient's veins.During this procedure the blood flew out of the extension tube of the nexiva single port when did the incident occur? before use.
Additional Manufacturer Narrative
Our quality engineer inspected the photo and 2 samples submitted for evaluation.The reported issues of blood leaks out of control plug and vent plug loose/ missing were confirmed upon inspection of the samples.Analysis of the samples showed the vent plug detached from the luer adapter in the packaging.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.An investigation was performed to check for the insertion of the vent plug into the luer adapter.The defect occurred due to a misalignment during the insertion process where the vent plug was not fully inserted into the luer.There is a visual system to check for missing component during packaging before proceeding to next process.The vent plug could also loosen during transportation to the next process.Action was taken in march 2025 to fabricate a bracket to secure holding the vent plug during insertion.

• Brand Name: BD NEXIVA 20 GA X 1-1/4 IN SINGLE PORT
• 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: 21527020
• Report Number: 2243072-2025-00210
• Device Sequence Number: 18533094
• Product Code: FOZ
• UDI-Device Identifier: 00382903835171
• UDI-Public: (01)00382903835171(11)240901(17)270831(10)4242368
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 04/28/2025

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: Health Professional
• Device Catalogue Number: 383517
• Device Lot Number: 4242368
• 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: 02/17/2025
• Supplement Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown