MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA DIFFUSICS 24G X 0.75 IN; INTRAVASCULAR CATHETER

Catalog Number	383590
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
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
It was reported that bd nexiva diffusics 24g x 0.75 leaked.It was reported by the customer that noted to not have filter on the end and caused bleeding from the end of the tubing as no typical need to hold pressure or clamp tubing.Incident or problem information.Reference number (id): (b)(4).Date of incident (yyyy-mm-dd): (b)(6) 2025.Level of harm: no apparent harm - reached the patient/person - inconvenient.Incident details: nexiva diffusics was noted to not have filter on the end and caused bleeding from the end of the tubing as no typical need to hold pressure or clamp tubing.Noted right away, resolved, no extreme blood loss, iv otherwise functioning well.No filter noted in the packaging.Procedure: iv insertion.Device information device name/description: catheter iv passive safety non-winged closed system yellow 24gax19mm nexiva diffusics.Manufacturer code/model: 383590.Serial or lot number: (b)(6).Device expiry date (yyyy-mm-dd): 2025-03-12.Supplier catalogue number: 333-383590.Was the device retained? no.
Additional Manufacturer Narrative
Investigation results: a device history record review was completed by our quality engineer team for provided material number 383590 and lot number 4345882.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
Additional information: total number of occurrences? 1 for this report.

• Brand Name: BD NEXIVA DIFFUSICS 24G X 0.75 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: 21766716
• Report Number: 9610847-2025-00086
• Device Sequence Number: 8648137
• Product Code: FOZ
• UDI-Device Identifier: 00382903835904
• UDI-Public: (01)00382903835904(11)250113(17)271130(10)4345882
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2025

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: 383590
• Device Lot Number: 4345882
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2025
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown