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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
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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).
 
Manufacturer Narrative
The following fields were updated due to additional information: d.4.Medical device lot #: 202016.Is correct.D.4.Medical device expiration date: unknown.D10: device available for eval yes.D10: returned to manufacturer on: 2021-01-13.H.4.Device manufacture date: unknown.Investigation summary: one mv0420-0006 from lot 202016 was received without packaging for investigation.The device was received with an intact vial containing medication attached to it.A visual inspection of the sample received did not identify any product defects or manufacturing issues which could have contributed to the customer¿s experience; additionally it appeared that the vial access device had been correctly positioned.Functional testing was performed on the smartsite with a retained 50ml bd plastipak syringe; fluid was able to be withdrawn from the vial with no signs of occlusion or flow resistanc.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 for lot 202016 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.It was not possible to confirm the root cause of the customer¿s experience in this instance.Testing of the returned sample did not identify any product defects or quality deviations that could have contributed to the customer¿s experience.In this instance the connecting product was not returned for investigation, and therefore it could not be determined if this may have contributed to the customer's experience.A review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the mv0420-0006 set in the past 12 months.
 
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).
 
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Brand Name
SMARTSITE 20MM VENTED 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 22244
MX  22244
MDR Report Key11103375
MDR Text Key246128338
Report Number9616066-2020-20705
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 03/16/2021
1 Device was Involved in the Event
1 Patient was 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
Date Manufacturer Received03/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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