MAUDE Adverse Event Report: BECTON DICKINSON BD NEXIVA 22GA 1.00IN Y W/ CAP; INTRAVASCULAR CATHETER

Catalog Number	383642
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 22ga 1.00in y w/ cap leakage at septum filter is loose in the packaging before use description of complaint filter is loose in packaging.As a result in 3 patients when inserting iv needle, blood ran back (tampering).No consequences for the patients.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Our quality engineer inspected the photos, and 15 representative samples submitted for evaluation.The reported issue of leakage at septum was not confirmed upon inspection of the samples.Analysis of the samples showed no damages or defects.Samples were subjected to a catheter air-water leak test and flashback test to check for leaks.No leakage was observed during testing.The investigation found the vent plug loose inside the packaging during transfer as the vent plug was plugged into the adapter with less force.Suspected the gripper is not aligned with the adapter during insertion.Modifications will be completed to secure the gripper mounting bracket and to prevent misalignment.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.The root cause for the leakage could not be determined as the defect was not replicated.Production records were reviewed, and this batch meets our manufacturing specification requirements.

• Brand Name: BD NEXIVA 22GA 1.00IN Y W/ CAP
• 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: 20789128
• Report Number: 2243072-2024-01167
• Device Sequence Number: 18095135
• Product Code: FOZ
• UDI-Device Identifier: 00382903836420
• UDI-Public: (01)00382903836420(11)240813(17)270731(10)4207287
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 02/13/2025

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: 383642
• Device Lot Number: 4207287
• 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: 11/04/2024
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 02/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown