MAUDE Adverse Event Report: BECTON DICKINSON NEXIVA; INTRAVASCULAR CATHETER

Catalog Number	383642
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
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 22ga 1.00in y w/ cap had plastic part around the needle is defective we hereby inform you of a complaint about the product quality, with the internal complaint number (b)(4) of the article 1x 4813444, bd nexiva kath syst 22g 0.9x25mm y-ver blue 20 pcs.Defect reported by the customer: plastic part around the needle is defective.The plastic should remain in the vein as soon as the needle is pulled out.This does not work.If you then pull out the needle including plastic, you can see a slit on plastic.When did the incident occur? during use.
Additional Manufacturer Narrative
Our quality engineer inspected the photo and 4 samples submitted for evaluation.The reported issue of needle defect - other was confirmed upon inspection of the samples.Analysis of the samples showed that the needle had pierced through the catheter on the 1 used sample.No damaged components were observed on the 3 representative samples.The unused samples passed a catheter air-water leak test and a retraction test with no failures detected.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records have been reviewed, and this batch meets our manufacturing specification requirements.It is possible that the needle pierced through the catheter during product application or during needle cover removal, particularly if not handled carefully.

• 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: 22531916
• Report Number: 2243072-2025-00887
• Device Sequence Number: 12621695
• Product Code: FOZ
• UDI-Device Identifier: 00382903836420
• UDI-Public: (01)00382903836420(11)241002(17)270930(10)4275719
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 09/18/2025

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: 4275719
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown