MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SMARTSITE 20MM CLOSED VIAL ACCESS DEVICE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number MV0520-0006

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2021

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.

Event Description

It was reported that 3 smartsite 20mm closed vial access devices experienced leakage.The following information was provided by the initial reporter: it has occurred in drugs that are reconstituted, and it seems like the balloon doesn't activate and so the internal pressure results in the drug leaking around the spike.We've had it happen twice with vials of trastuzumab emtansine, and with bendamustine.We have 8 full unopened boxes, plus stock that has been removed from the box.

Manufacturer Narrative

Investigation summary: a mv0520-0006 sample was not available for investigation, however the customer confirmed that the complaint sample was from lot: 9248.From the information provided by the customer it appears that leakage is observed from around the spike of the vial access device during attempts to reconstitute drugs.The details of this feedback were shared with the legal manufacturer of the product, yukon medical llc, for investigation.A review of the production records from lot: 9248 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The root cause of the customer¿s experience could not be determined as the sample was not available for investigation.In this instance, without a sample it is not possible to determine whether a manufacturing defect could have caused or contributed to the reported leakage.A review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the mv0520-0006 product in the past 12 months.

Event Description

It was reported that 3 smartsite 20mm closed vial access devices experienced leakage.The following information was provided by the initial reporter: it has occurred in drugs that are reconstituted, and it seems like the balloon doesn't activate and so the internal pressure results in the drug leaking around the spike.We've had it happen twice with vials of trastuzumab emtansine, and with bendamustine.We have 8 full unopened boxes, plus stock that has been removed from the box.

• Brand Name: SMARTSITE 20MM CLOSED VIAL ACCESS DEVICE
• Type of Device: INTRAVASCULAR ADMINISTRATION 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12667926
• MDR Text Key: 277675667
• Report Number: 9616066-2021-52267
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• 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: 11/16/2021

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: 11/28/2022
• Device Catalogue Number: MV0520-0006
• Device Lot Number: 9248
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2021
• Initial Date FDA Received: 10/20/2021
• Supplement Dates Manufacturer Received: 11/16/2021
• Supplement Dates FDA Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2020
• 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