MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA DIFFUSICS W/MAXZERO 20G X 1.75 IN; INTRAVASCULAR CATHETER

Catalog Number	383599
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd nexiva diffusics w/maxzero 20g x 1.75 in leaked it was reported by customer that the leaking at the hub before extension set verbatim: leaking at the hub before extension set.
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 physical sample submitted for evaluation.The reported issue of leakage was confirmed upon inspection and testing of the samples.Analysis of the sample showed that during the functional testing, leak test, a leak was observed at the junction of the tubing with the luer adapter.A visual inspection of the device showed what looks to be damage to the tubing which was causing the leak.Bd was not able to determine the cause of the failure, throughout our manufacturing process there are flow controls capable of rejecting parts that do not meet the specifications for flow.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.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: BD NEXIVA DIFFUSICS W/MAXZERO 20G X 1.75 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: 22236031
• Report Number: 9610847-2025-00195
• Device Sequence Number: 8176545
• Product Code: FOZ
• UDI-Device Identifier: 00382903835997
• UDI-Public: (01)00382903835997
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K233529
• 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): 07/30/2025

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: 383599
• Device Lot Number: UNKNOWN
• 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: 05/28/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown