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

Catalog Number 383517

Device Problem Leak/Splash (1354)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd nexiva was leaking the following information was received by the initial reporter with the following verbatim: the clinical staff punctured the patient with an indwelling needle.After removing the needle core, blood leaked from the needle core channel, causing the patient to be punctured again.The patient and his family were dissatisfied.

Manufacturer Narrative

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 383517 and lot number 3116950.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.

• Brand Name: BD NEXIVA
• Type of Device: 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: 19126315
• MDR Text Key: 341289970
• Report Number: 1710034-2024-00335
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835171
• UDI-Public: (01)00382903835171
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

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
• Device Operator: Other
• Device Catalogue Number: 383517
• Device Lot Number: 3116950
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/17/2024
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1