• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SMARTSITE 20MM VENTED VIAL ACCESS DEVICE INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number MV0420-0006
Device Problems Difficult to Remove (1528); Difficult or Delayed Separation (4044)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/03/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device lot #: the customer provided lot # 202016. This does not match the catalog number provided. Medical device expiration date: unknown. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. Device manufacture date: unknown. (b)(4).
 
Event Description
It was reported that smartsite 20mm vented vial access device was difficult to disconnect. The following information was provided by the initial reporter: i would like to inform you of an incident that occurred while using your device: vented vial access device 20mm. After striking a bottle of paclitaxel (hospira) with the spike mentioned above: cannot remove the liquid from the bottle. The operator tried several times to pull the piston out of his spike-screwed syringe, without success, even after testing to inject air into the vial with the syringe: it is not possible to use the well-adapted device on the bottle. A new spike must have been used to hit a new bottle. This incident has occurred several times with the specialty paclitaxel but also with other cytotoxic substances (notably zaltrap).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSMARTSITE 20MM VENTED VIAL ACCESS DEVICE
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
blvd. insurgentes no. 20351
parque industrial el florido
tijuana 22244
MX 22244
Manufacturer (Section G)
SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
blvd. insurgentes no. 20351
parque industrial el florido
tijuana 22244
MX 22244
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11103375
MDR Text Key246128338
Report Number9616066-2020-20705
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberMV0420-0006
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/13/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/16/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-