MAUDE Adverse Event Report: BECTON DICKINSON NEXIVA 20GA 1.25IN HF Y W/ CAP; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number	383647
Medical Device Problem Codes	Leak/Splash (1354); Separation Failure (2547)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Nurses use it normally and leakage occurs.
Event or Problem Description
It was reported that leakage at septum and difficulty withdrawing needle core occurred.On (b)(6) 2025 customer response: blood leaks from the isolation where the needle core is withdrawn and the needle tip guard cannot be activated.
Additional Manufacturer Narrative
Additional information: additional failure reported.Annex a codes updated.Original failure specification received.Noted in b.Correction: re-translation of documents- new device applied.E/f codes updated.
Additional Manufacturer Narrative
Investigation results: a device history record review was completed by our quality engineer team for provided material number 383647 and lot number 2125809.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.
Event or Problem Description
No additional information.

• Brand Name: NEXIVA 20GA 1.25IN HF Y W/ CAP
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• 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: 20925627
• Report Number: 1710034-2024-01490
• Device Sequence Number: 17425512
• Product Code: FOZ
• UDI-Device Identifier: 00382903836475
• UDI-Public: (01)00382903836475(11)220505(17)250430(10)2125809
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 02/05/2025

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: 04/30/2025
• Device Catalogue Number: 383647
• Device Lot Number: 2125809
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: Not provided; 02/05/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 01/28/2025; 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown