MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA 18 GA X 1.25IN SP WITH MAXZERO; INTRAVASCULAR 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	08/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd nexiva 18 ga x 1.25in sp with maxzero leaked.It was reported by the customer that our bd nexiva (18 and 20 gauge) has leaked out of the gray stopper where the needle comes out.It pours out blood and we have to restart the iv.Verbatim: er has mentioned a couple times that our bd nexiva (18 and 20 gauge) has leaked out of the gray stopper where the needle comes out.It pours out blood and we have to restart the iv.I have the example from today in a bag with the top paper that has iv info.Do you want this? for example, when you take the needle part out like the picture below, blood is pouring out of the stopper (the picture shows white¿.Ours is gray).
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 complaint of a leak from the catheter septum was confirmed and the cause appeared to be manufacturing related.One used 18g nexiva iv catheter and one photograph were provided for investigation.What appeared to be blood residue had bypassed the septum.The septum was noted to be smeared between the cannister and catheter adapter, which likely occurred during assembly due to misalignment.The appropriate manufacturing personnel were notified of this complaint.Actions are being taken at the manufacturing facility to further address this defect.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.
Event or Problem Description
No additional information.

• Brand Name: BD NEXIVA 18 GA X 1.25IN SP WITH MAXZERO
• 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): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; colosio no. 579; sandy UT 84070
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20079767
• Report Number: 9610847-2024-00237
• Device Sequence Number: 20728017
• Product Code: FOZ
• UDI-Device Identifier: 00382903835591
• UDI-Public: (01)00382903835591
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 10/17/2024

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: 4059683
• 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: 08/05/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown