MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. NEXIVA DUAL PORT WITH Q-SYTE, 20G X 1.0; INTRAVASCULAR CATHETER

Model Number 383536

Device Problem Leak/Splash (1354)

Patient Problem Rupture (2208)

Event Date 03/16/2022

Event Type  malfunction  

Event Description

It was reported while using nexiva dual port with q-syte, 20g x 1.0 leakage occurred.The following information was provided by the initial reporter: in the middle of the examination, the procedure must be stopped due to contrast explosion, since the psi of the syringe exceeded that of the device.

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary: our quality engineer inspected the photographs submitted for evaluation.Bd received two photographs which displayed a representative unit in the sealed package.The photographs provided for this incident did not present sufficient evidence to identify or confirm the alleged failure or to establish a definite root cause.Per the ifu (instructions for use), it may be caused by exceeding the maximum power injector pressure of 300psi during the power injection.A device history record review showed no non-conformances associated with this issue during the production of this batch.

Event Description

It was reported while using nexiva dual port with q-syte, 20g x 1.0 leakage occurred.The following information was provided by the initial reporter: in the middle of the examination, the procedure must be stopped due to contrast explosion, since the psi of the syringe exceeded that of the device.

• Brand Name: NEXIVA DUAL PORT WITH Q-SYTE, 20G X 1.0
• Type of Device: INTRAVASCULAR CATHETER
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14015507
• MDR Text Key: 288613923
• Report Number: 1710034-2022-00171
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835363
• UDI-Public: 30382903835363
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K102520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/02/2022

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: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: 383536
• Device Catalogue Number: 383536
• Device Lot Number: 1068454
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2022
• Initial Date FDA Received: 04/05/2022
• Supplement Dates Manufacturer Received: 06/02/2022
• Supplement Dates FDA Received: 07/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1