MAUDE Adverse Event Report: BECTON DICKINSON NEXIVA 24 GA X 9/16 IN SINGLE PORT; INTRAVASCULAR CATHETER

Catalog Number	383510
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
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 24 ga x 9/16 in single port - catheter defective / damaged.It was reported by customer that catheter straw kinked and slightly cracked.
Additional Manufacturer Narrative
Our quality engineer inspected the 1 photo and 1 physical sample submitted for evaluation.The reported issue of catheter defective / damaged was confirmed upon inspection of the samples.Analysis of the sample showed that under magnification bd was able to observe the damage to the catheter.Bd determined that the cause of the failure was most likely attributed to improper handling during use, after opening the package and/or placing the device.Bd has systems in place throughout the manufacturing process capable of detecting parts with this type of defect and segregating them as rejected.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.

• Brand Name: NEXIVA 24 GA X 9/16 IN SINGLE PORT
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales UT ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22962383
• Report Number: 9610847-2025-00291
• Device Sequence Number: 8453017
• Product Code: FOZ
• UDI-Device Identifier: 00382903835102
• UDI-Public: (01)00382903835102(11)241220(17)271130(10)4333052
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2025

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: 383510
• Device Lot Number: 4333052
• 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: 08/18/2025
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown