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

Catalog Number	383593
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Material # 383593 batch #5182130.It was reported by customer that iv catheter snapped at the connection of the tubing to the hub while inserting the catheter into the patient.The iv separated at this connection.Verbatim: rcc received a complaint via email.Email(s) attached.(b)(6) reference number (id): date of incident (yyyy-mm-dd): 2026-02-08 type of incident/problem: a2.Failure (i.E.While preparing for, in use, after use) level of harm: moderate harm (b)(6) optional report to cmdsnet (health canada): incident details: iv catheter snapped at the connection of the tubing to the hub while inserting the catheter into the patient.The iv separated at this connection.Impact of incident: ["had to remove iv and re-insert a new iv in a different location.Blood exposure at the site of the disconnection potential for exposure."] who was affected? patient unexpected or prolonged care? yes frequency of problem: first time other device/incident factors: invasive procedure? yes procedure: iv insertion physician: unsure device information device name/description: catheter iv passive safety non-winged closed system pink 20gax31.75mm nexiva diffusics manufacturer: manufacturer code/model: 383593 serial or lot number: (b)(6) expiry date: 2028-06-30 supplier: supplier/catalogue number: is the device retained? yes number of devices: wiped, contained, labelled? device handling hazards (when blank = hazards not specified) investigation request expected type of investigation: actual device tested; lot review; report history/trend analysis; shipping instructions request date (yyyy-mm-dd): 2026-02-11 e-mail address for person holding device: site shipping address:.
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 3 photos and 1 physical sample submitted for evaluation.The reported issue of catheter broke / separated after placement was confirmed upon inspection of the samples.Analysis of the sample showed that the reported defect was observed.Bd determined that the cause of the failure was lack of curing of bonding adhesive and incorrect or non-application of test to confirm secure bond.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: NEXIVA DIFFUSICS
• 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: 24444430
• Report Number: 9610847-2026-00073
• Device Sequence Number: 16045498
• Product Code: FOZ
• UDI-Device Identifier: 00382903835935
• UDI-Public: (01)00382903835935(11)250708(17)280630(10)5182130
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 04/14/2026

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: 383593
• Device Lot Number: 5182130
• 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: 02/11/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown