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

Catalog Number	383590
Medical Device Problem Codes	Leak/Splash (1354); Material Integrity Problem (2978); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that the hole noted to cathlon before needle retracted, dripping down side of cathlon.Tried flushing and drawing bloodwork but syringe w filled w/air/blood from the hole to cathlon.Verbatim: rcc received a complaint via email.Email(s) attached.Product information product code: 383590 product description: catheter iv closed nexiva diffusics lot/serial #: n/a expiry date: n/a problem information hole noted to cathlon before needle retracted, dripping down side of cathlon.Tried flushing and drawing bloodwork but syringew filled w/air/blood from the hole to cathlon.Occurrences: 1 reporter information **** site information hsc *** sample information incident samples: n/a representative samples: n/a.
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: the reported defect could not be refuted nor confirmed in the absence of a sample.The root cause cannot be determined for an unconfirmed defect.A complaint history (chr) review could not be performed as no batch/lot number was made available for this reported event.A device history record (dhr) review could not be performed as no batch/lot number was made available for this reported event.Process documents were reviewed and there are proper controls in place to detect product malfunctions.
Event or Problem Description
No additional information.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the 1 photo and 1 physical sample submitted for evaluation.The reported issue of catheter defective / damaged was confirmed upon inspection and testing of the samples.Analysis of the sample showed that under magnification the damage to the catheter was observed.A leak test was performed and a leakage was observed.After an evaluation of the processes where this defect could possibly have been caused, 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.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: 24294702
• Report Number: 9610847-2026-00050
• Device Sequence Number: 21188831
• Product Code: FOZ
• UDI-Device Identifier: 00382903835904
• UDI-Public: (01)00382903835904
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/09/2026

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: 383590
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 02/12/2026; 04/09/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 02/18/2026; 04/14/2026
• 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