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

Catalog Number	383512
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
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
The flexible catheter is the part that bent.The needle appears to have punctured through it.The nurse said that she didn¿t do anything differently than insertions with these new ivs that she successfully placed.Customer responded on (b)(6) 2025 describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.No injury to the patient.The iv insertion attempt had to be aborted, however, because the malfunction would not allow the nurse to advance the catheter.A second rn placed a different iv following the event.
Additional Manufacturer Narrative
The complaint of the needle puncturing the catheter was confirmed and the cause appeared to be associated with use.Two photographs were provided for investigation, which showed a needle protruding through the 22g nexiva iv catheter tubing.The tubing was bent at the puncture site.The sample exhibited evidence of use.Due to the presence of what appeared to be blood residue within the catheter tubing, it appeared that the device was able to access the vessel.The instructions for use (ifu) state, "if the needle is partially or completely withdrawn from the catheter tubing during insertion, do not re-insert the needle into the catheter tubing as damage may occur." no defects associated with the manufacturing process could be identified from the photograph.Manufacturing controls are in place to mitigate the occurrence of this type of failure.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.
Event or Problem Description
No new information.

• 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: 23442223
• Report Number: 1710034-2025-01712
• Device Sequence Number: 15586877
• Product Code: FOZ
• UDI-Device Identifier: 00382903835126
• UDI-Public: (01)00382903835126(11)250501(17)280430(10)5120903
• 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,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2025

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 Catalogue Number: 383512
• Device Lot Number: 5120903
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown