MAUDE Adverse Event Report: BECTON DICKINSON NEXIVA DIFFUSICS 20G X 1.00 IN; INTRAVASCULAR CATHETER

Catalog Number	383592
Medical Device Problem Codes	Leak/Splash (1354); Material Integrity Problem (2978)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd nexiva diffusics 20g x 1.00 in - catheter defective / damaged.Verbatim: this is from the rn: good morning, i'm so sorry for the delay i have been away on vacation for back to school - i prepped the patient in usual fashion after sterilizing area i applied tourniquet pt had beautiful easily accessible veins and patient laid still during entire procedure when i stuck his left ac i got flash and started to advance catheter blood started leaking completely around the iv and not in the catheter i continued to attempt to advance and withdraw needle in which it was then made obvious the catheter itself was fractured- i pulled everything from site then had to manually manipulate the small fractured piece out of the vessel to protect the patient and prevent catastrophic injuries.I was able to do this successfully at which i placed a pressure dressing and then notified chain of command of what had happened.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Our quality engineer inspected the 2 photos 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 it was possible to observe the defect reported by the customer.Bd was not able to determine the cause of the failure because there are current controls in place such as 100% double inspection.A notification will be shared to all personnel involved in the catheter and needle assembly process.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 DIFFUSICS 20G X 1.00 IN
• 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: 22851742
• Report Number: 9610847-2025-00267
• Device Sequence Number: 8421935
• Product Code: FOZ
• UDI-Device Identifier: 00382903835928
• UDI-Public: (01)00382903835928(11)250410(17)280331(10)5084959
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K173354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• 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: 383592
• Device Lot Number: 5084959
• 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: 08/07/2025
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown