MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA SINGLE PORT; PERIPHERAL IV CATHETERS

Catalog Number	383510
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.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 single port leaked at the septum.The following information was provided by the initial reporter: as per customer "item is not working, trying to draw blood, blood not going through the line, when removed from the part bloods are coming out." (b)(6).1.Could you please confirm if the statement 'bloods are coming out' refers to leakage from the device? the customer said when the nurse put the needle in the blood would not flow through the line and when they removed the needle from the arm blood was dripping like it was stuck but wouldn't flow through the line.2.If there is a leakage, could you specify where the leakage is coming from? when they pull out the needle.Was there an injury: no.Was there a death: no.(b)(6) 2025.Could you please confirm if the returned batches were affected? yes.Are these batches associated with different complaints? no.Was there any harm to the patient/caregiver? no.
Additional Manufacturer Narrative
No photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.
Additional Manufacturer Narrative
Our quality engineer inspected the representative sample submitted for evaluation.The reported issue of leakage at septum was not confirmed upon inspection of the sample.Analysis of the sample showed no damage or defects.The sample was subject to flashback and air water leak tests to ensure there was no clogged product.The sample passed with no abnormalities observed.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records have been reviewed, and this batch meets our manufacturing specification requirements.The root cause could not be determined as the defect was not replicated.

• Brand Name: BD NEXIVA SINGLE PORT
• Common Device Name: PERIPHERAL IV CATHETERS
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22084833
• Report Number: 1710034-2025-00897
• Device Sequence Number: 6906453
• Product Code: FOZ
• UDI-Device Identifier: 00382903835102
• UDI-Public: (01)00382903835102(11)220330(17)250930(10)2089644
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Distributor
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/06/2025

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 Expiration Date: 09/30/2025
• Device Catalogue Number: 383510
• Device Lot Number: 2089644
• 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: 05/08/2025
• Supplement Date Received by Manufacturer: 06/17/2025; 08/06/2025
• Initial Report FDA Received Date: 05/26/2025
• Supplement Report FDA Received Date: 06/18/2025; 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown