MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA 18 GA X 1.25IN SP WITH MAXZERO; PERIPHERAL IV CATHETER

Catalog Number	383559
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
It was reported that bd nexiva 18 ga x 1.25in sp with maxzero leaked.The following information was provided by the initial reporter: three different nexiva catheters have been leaking where the stabilization platform meets the tubing, near the hub of the catheter.All 18g within the past week, inserted by a proficient icu nurse.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: the complaint of a leak could not be confirmed as the device was not provided for investigation.The top web label from a unit package was provided for investigation.An arrow was drawn on the label in blue ink, which pointed to an image printed on the label where the extension tube is bonded to the catheter adapter, which coincides with the location of the reported leak.Since the leak could not be confirmed without a physical sample, the complaint was inconclusive.A review of the inspection records and quality/manufacturing controls for the implicated lot indicated no issues with the manufacturing process.The complaint has been documented and will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.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.

• Brand Name: BD NEXIVA 18 GA X 1.25IN SP WITH MAXZERO
• Common Device Name: PERIPHERAL IV CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19654225
• Report Number: 1710034-2024-00674
• Device Sequence Number: 6623886
• Product Code: FOZ
• UDI-Device Identifier: 00382903835591
• UDI-Public: (01)00382903835591
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K183399
• 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): 09/03/2024

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: 383559
• Device Lot Number: 3298969
• 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: 06/12/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown