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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
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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SMARTSITE 20MM VENTED VIAL ACCESS DEVICE Back to Search Results
Catalog Number MV0420-0006
Device Problems Complete Blockage (1094); Restricted Flow rate (1248); Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/03/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device lot #: an invalid lot # of 202040 was provided by the initial reporter.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
 
Event Description
It was reported that the smartsite 20mm vented vial access device experienced flow issues, was clogged/blocked/occluded, experienced leakage, and experienced device damage/deformation while still considered operable.The following information was provided by the initial reporter: the paclitaxel vial is hit by a spike: 1st sampling does not show any problem.Then during a second sampling, it is impossible to withdraw the liquid, as the syringe plunger is inactivated (by pulling or pushing).Caution: paclitaxel leaked on the vial.No clinical consequences for the operator or the patient.
 
Manufacturer Narrative
The following fields were updated due to additional information: d4: medical device lot #: 202040.D4: medical device expiration date: unknown.H4: device manufacture date: unknown.D10: device available for eval yes.D10: returned to manufacturer on: 2021-04-13.H6: investigation summary one mv0420-0006 sample from lot 202040 was received attached to a vial access device (vad) that was inserted into a glass bottle of paclitaxel.The sample was received without packaging and with residual fluid in the device.Functional testing of the returned (b)(6) sample confirmed that the smartsite could be easily detached from the vad after manually twisting the smartsite.In addition, functional testing was performed on the smartsite with a retained 50ml bd plastipak syringe; no flow restriction or occlusion was observed throughout testing.The details of this feedback were shared with the legal manufacturer of the product, yukon medical llc, for investigation.A definitive root cause for the reported occlusion could not be determined in this instance, as no occlusion was identified during testing of the returned sample.However during the testing the smartsite was observed to have separated from the vad; a definitive root cause for the separation could not be determined in this instance, however it is possible that it occurred as a result of an inconsistent or insufficient application of glue, coupled with the force being applied to the smartsite during engagement or disengagement of the connecting product.A review of the production records from lot 202040 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.In order to ensure that reports of this nature are reduced, yukon medical llc, have implemented additional in-process testing during future production of this product.A review of the customer feedback database indicates that there have been no further reports for occlusion against the (b)(6) product in the past 12 months, however there have been a small number of similar reports for separation of the smartsite.
 
Event Description
It was reported that the smartsite 20mm vented vial access device experienced flow issues, was clogged/blocked/occluded, experienced leakage, and experienced device damage/deformation while still considered operable.The following information was provided by the initial reporter: the paclitaxel vial is hit by a spike: 1st sampling does not show any problem.Then during a second sampling, it is impossible to withdraw the liquid, as the syringe plunger is inactivated (by pulling or pushing).Caution: paclitaxel leaked on the vial.No clinical consequences for the operator or the patient.
 
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Brand Name
SMARTSITE 20MM VENTED VIAL ACCESS DEVICE
Type of Device
VIAL ACCESS DEVICE
Manufacturer (Section D)
SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
blvd. insurgentes no. 20351
parque industrial el florido
tijuana
MDR Report Key11590009
MDR Text Key263607449
Report Number9616066-2021-50613
Device Sequence Number1
Product Code LHI
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 06/10/2021
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 Catalogue NumberMV0420-0006
Device Lot Number202040
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/13/2021
Initial Date Manufacturer Received 03/04/2021
Initial Date FDA Received03/30/2021
Supplement Dates Manufacturer Received06/10/2021
Supplement Dates FDA Received06/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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