MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA DIFFUSICS 22G X 1.00 IN; INTRAVASCULAR CATHETER

Catalog Number	383591
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd nexiva diffusics 22g x 1.00 in needle through catheter.It was reported by customer that "when partially pulling back needle in 22 gauge iv and reinserting, needle is puncturing iv catheter and splitting catheter in two." verbatim: rcc received a complaint via email.Email(s) attached.When partially pulling back needle in 22 gauge iv and reinserting, needle is puncturing iv catheter and splitting catheter in two.Has happened multiple times with this lot number of iv sets.Lot# 4303911.Additional information received on 24th june 2025: it happened on 2 different patients and then was recreated by poking a saline bag.
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
No additional information.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the 2 photos submitted for evaluation.The reported issue of needle through catheter was confirmed upon inspection of the photos.Analysis of the sample showed that the used device has the needle protruding through the catheter.However, bd cannot confirm the cause of the failure to manufacturing since controls are in place throughout the device assembly that are capable of segregating defects of this type.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.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD NEXIVA DIFFUSICS 22G X 1.00 IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22373276
• Report Number: 9610847-2025-00207
• Device Sequence Number: 18149055
• Product Code: FOZ
• UDI-Device Identifier: 00382903835911
• UDI-Public: (01)00382903835911(11)241118(17)271031(10)4303911
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K173354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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: 383591
• Device Lot Number: 4303911
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 12/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown