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

Catalog Number	383591
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that bd nexiva diffusics 22g x 1.00 in catheter broke / separated after placement it was reported by customer that this pertains to a series safety event involving a patient, during which the catheter broke off while in place.Verbatim: rcc received a complaint via email.Cat# of product being complained: bd383591 description of product: guide flow rate cath 22gax1in nexiva 20ea/bx 4bx/ca lot or s/n: (b)(6) complaint category: fail to function / defective reportable: no incident date: (b)(6) 2026 hospital complaint reference #: details of complaint (reported issue): this complaint pertains to a series safety event involving a patient, during which the catheter broke off while in place.Additional information & photos will be sent via separate email.Complaint noticed: during / after use problem frequency: 1st time patient injury: no qty affected: (b)(4) samples available? no is customer requesting an rga?: no return qty: customer response on (b)(6) 2025.That is correct, the incident date was (b)(6) 2025.
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
Per additional feedback, this mdr has been corrected to a product problem and si.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the 1 photo submitted for evaluation.The reported issue of catheter broke/separated after placement was confirmed upon inspection of the sample.Analysis of the sample showed that the reported defect was observed.However, bd was not able to determine the cause of the failure.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
Customer response on 06-aug-2025.Yes, in attempts to remove the broken piece of catheeter, multiple diagnostic examinations were completed to visualize and physician intervention took place.

• 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: 22693117
• Report Number: 9610847-2025-00237
• Device Sequence Number: 20895751
• Product Code: FOZ
• UDI-Device Identifier: 00382903835911
• UDI-Public: (01)00382903835911(11)250117(17)271231(10)5010696
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 383591
• Device Lot Number: 5010696
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Supplement Date Received by Manufacturer: Not provided; 08/19/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 08/08/2025; 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown