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	11/01/2024
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 in leaked.It was reported by customer that 2 more defective nexivas to return.When went to power inject at a rate of 2/sec iv infiltrated.On the second one when went to hand inject iv infiltration verbatim#: rcc received a complaint via email.We have 2 more defective nexivas to return.Both of them are ref (b)(4), both are lot: 4176473.What was the impact to the patient? infiltrated.Patient will need to return.Can you please provide an exact date of event in format dd-mmm-yyyy? 10/31/2024 and 11/1/2024.Can you please provide the lot number associated with reported issue? ref: (b)(4), lot 4176473.Sample available is mentioned as yes, are you able to provide the address of the facility for us to ship the return label? xx.Customer response: 1.Please provide the issue in detail.When went to power inject at a rate of 2/sec iv infiltrated.On the second one when went to hand inject iv infiltration.2.Please describe the term "defect nexivas".What type of defect is that? do not know exact ¿defect¿ but all of a sudden, we are getting infiltrates with technologist that haven¿t have infiltrates in 20 years.¿something is amiss¿.3.Please share the captured photo of the event if available.No photo.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the 2 physical samples submitted for evaluation.The reported issue of leakage was not confirmed upon inspection and testing of the samples.Analysis of the sample showed that no anomaly was detected.Bd could not determine a manufacturing related root cause since the reported defect was not confirmed during the evaluation of the sample.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: 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: 20781432
• Report Number: 9610847-2024-00360
• Device Sequence Number: 9032649
• Product Code: FOZ
• UDI-Device Identifier: 00382903835904
• UDI-Public: (01)00382903835904(11)240708(17)270531(10)4176473
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K173354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2024

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: 4176473
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2024
• Supplement Date Received by Manufacturer: 12/23/2024
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown