MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE; IV FLUID TRANSFER SET

Model Number MV0400

Device Problems Difficult to Insert (1316); Leak/Splash (1354)

Patient Problems Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Date of birth: patient¿s birthday was not provided, (b)(6) 2006 was used based on age of patient.Medwatch report # mw 5233000000-2022-8006.

Event Description

It was reported that the bd smartsite¿ vented vial access device was push down into the vial body causing the medication to waste and increase exposure to staff.The following information was provided by the initial reporter: the bd mv0400 universal vial access is not able to access small 1ml and 2ml vials.Instead of spiking and piercing through the septum, the septum is pushed down into the vial body by this access device.This causes medication waste and increased exposure to staff as some of the medications are harmful.

Manufacturer Narrative

H6: investigation summary no product or photo was returned by the customer.The customer complaint of septum being pushed into the body rather than breaking at the spike point could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on material mv0400 and lot 202035 as this is a supplier complaint.The quality engineer for this supplier has been notified of the issue.The root cause of this failure could not be identified without a failure investigation.

Event Description

It was reported that the bd smartsite¿ vented vial access device was push down into the vial body causing the medication to waste and increase exposure to staff.The following information was provided by the initial reporter: the bd mv0400 universal vial access is not able to access small 1ml and 2ml vials.Instead of spiking and piercing through the septum, the septum is pushed down into the vial body by this access device.This causes medication waste and increased exposure to staff as some of the medications are harmful.

• Brand Name: BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE
• Type of Device: IV FLUID TRANSFER SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16011016
• MDR Text Key: 308444817
• Report Number: 9616066-2022-02004
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2023

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 Expiration Date: 09/17/2023
• Device Model Number: MV0400
• Device Catalogue Number: MV0400
• Device Lot Number: 202035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2022
• Initial Date FDA Received: 12/19/2022
• Supplement Dates Manufacturer Received: 02/07/2023
• Supplement Dates FDA Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2020
• 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
• Patient Age: 17 YR
• Patient Sex: Female