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

Catalog Number	383551
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation results: the complaint that the needle had gone through the iv catheter tubing was confirmed and the cause appeared to be associated with use.One 24g nexiva device from lot 4215289 was provided for investigation.The needle was protruding through the side of the catheter tubing.The section of tubing between the puncture site and the catheter tip contained what appeared to be blood residue, which indicates that the needle and iv catheter tubing likely accessed the vessel.The instructions for use (ifu) state, "if the needle is partially or completely withdrawn from the catheter tubing during insertion, do not re-insert the needle into the catheter tubing as damage may occur."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 were identified on the returned sample.Manufacturing controls are in place to mitigate the occurrence of this type of failure.A review of manufacturing records did not find any issue related to the failure during the production of this batch.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.
Event or Problem Description
It was reported that bd.The following information was provided by the initial reporter: rn went to start the patient iv for treatment.Rn inserted the angiocath and when she went to withdraw the needle from the angiocath.Patient complained of pain and when nurse pulled the iv she found that the needle had gone through the plastic sheath, angiocath was a 24 gauge x 0.75 in bd nexiva.Lot number was 4215289.This is the second incidence of this, this week by 2 different rn's.(b)(6).Please provide the date of event.11/15/24.
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.E1.Street address information was not provided, therefore, was used as a place holder.

• Brand Name: BD NEXIVA SP WITH MAXZERO
• 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: 20854775
• Report Number: 1710034-2024-01434
• Device Sequence Number: 8905213
• Product Code: FOZ
• UDI-Device Identifier: 00382903835515
• UDI-Public: (01)00382903835515(11)240802(17)270731(10)4215289
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2025

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: 383551
• Device Lot Number: 4215289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2024
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown