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

Catalog Number	383538
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.The date received by manufacturer has been used for this field.
Event or Problem Description
It was reported that bd nexiva leaked at a connection the following information was provided by the initial reporter: the iv needle leaked to the double lumen during the injection of the patient at the connection.
Event or Problem Description
"has there been any impact on the patient (serious injury, medical intervention, change of treatment required)? = yes, patient had to be re-pricked, is a patient who is difficult to prick.".
Additional Manufacturer Narrative
Additional information received regarding patient.E/f codes updated.
Additional Manufacturer Narrative
Investigation results: no photographic evidence or physical samples were accessible to investigate the reported condition.Our quality engineer team conducted a comprehensive review of the device history record for the provided material number 383538 and lot number 3241214.This review did not uncover any abnormalities during the production process that could have caused this defect, and all quality tests were found to be within the specified standards.Unfortunately, the exact cause of this incident could not be determined based on the information available.We will continue to track and analyze complaints related to this device and the reported condition in order to identify any emerging trends.
Event or Problem Description
No additional information.

• Brand Name: BD 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: 19397590
• Report Number: 1710034-2024-00493
• Device Sequence Number: 7762180
• Product Code: FOZ
• UDI-Device Identifier: 00382903835386
• UDI-Public: (01)00382903835386
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2024

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: Other
• Device Expiration Date: 07/31/2026
• Device Catalogue Number: 383538
• Device Lot Number: 3241214
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2024
• Supplement Date Received by Manufacturer: Not provided; 06/24/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 06/10/2024; 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown