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

Catalog Number	383572
Medical Device Problem Codes	Leak/Splash (1354); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd nexiva 22ga x 1.00 in dp with maxzero leaked it was reported that "two medical device incidents that occurred on (b)(6) 2025 and (b)(6) 2026 in the medical imaging department of (b)(6) hospital." these incidents concern the same medical device: - name: nexiva blue 22g positive pressure valve peripheral venous catheter - supplier reference: 383572 - batch number: 4220636 descriptions of the incident on (b)(6) 2025 : "heavy bleeding during patient infusion.Merm rinsed to see what was happening.Leakage of saline solution.System not permeable with a ¿hole¿.Description of the incident on (b)(6)2026: ¿while inserting the catheter into the patient, the needle went through the catheter, forcing me to reinsert the patient.¿ the devices are at the pharmacy and are available if you wish to take them back for examination.
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
Investigation results: our quality engineer inspected the 1 photo and 1 physical sample submitted for evaluation.The reported issues of needle through catheter and leakage were confirmed upon inspection and testing of the sample.Analysis of the sample showed that visual inspection under magnification showed no damage to the catheter/adapter area.A leak test was performed and leakage was confirmed at the catheter/adapter junction.Bd was not able to determine the cause of the failure.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.
Event or Problem Description
No additional information.

• Brand Name: NEXIVA MAXZERO
• 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: 24235187
• Report Number: 9610847-2026-00042
• Device Sequence Number: 8980773
• Product Code: FOZ
• UDI-Device Identifier: 00382903835720
• UDI-Public: (01)00382903835720(11)240826(17)270731(10)4220636
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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: 383572
• Device Lot Number: 4220636
• 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: 01/16/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown