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

Catalog Number	383539
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Please give a product description : drip punctured patient.Wanted to draw blood from this and then it started leaking.Turned out there was a hole in the tube, so i had to puncture a new drip.On inserting the drip, the drip turns out to be faulty.There is a rupture in the tubing, which caused blood to leak out immediately.Bleeding was controlled immediately, and the patient did not lose more than an estimated 20cc of blood.As a result, the patient did have to have a second puncture.Has this product already been used in patients? : yes.Has there been any risk to the patient or user? : yes.
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
No new information.
Additional Manufacturer Narrative
The complaint of a hole in the tube was confirmed and the cause appeared to be manufacturing related.Four photographs were provided for investigation, which showed an 18g nexiva iv catheter with evidence of use.A circumferential breach was observed in the tubing.This type of damage can occur during manufacturing if the grippers are damaged.The appropriate manufacturing personnel were notified of this complaint.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.

• Brand Name: NEXIVA
• 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 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: 23799471
• Report Number: 1710034-2025-01948
• Device Sequence Number: 14719366
• Product Code: FOZ
• UDI-Device Identifier: 00382903835393
• UDI-Public: (01)00382903835393(11)250529(17)280531(10)5148487
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2026

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: 383539
• Device Lot Number: 5148487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2025
• Supplement Date Received by Manufacturer: 01/02/2026
• Initial Report FDA Received Date: 12/14/2025
• Supplement Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown