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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 7-DAY LL VLV ADPT(STAND ALONE); EXTENSION SET
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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 7-DAY LL VLV ADPT(STAND ALONE); EXTENSION SET Back to Search Results
Catalog Number 2000E7D
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/17/2020
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.(b)(4).
 
Event Description
It was reported that the 7-day ll vlv adpt(stand alone) experienced leakage.The following information was provided by the initial reporter: leaking and non functional.Iv bungs unable to use due to leaking and hard to connect the needle to it.No further details on when occurred and if product was attempted to be used or attached to a patients iv or seen to be faulty prior to use.Email sent to confirm sample availability, quantity affected and product code as document and email provided stated incorrect code 200037d however link in document referenced 2000e7d.Apologies the correct code is the 2000e7d.No issue with the packaging.Several reports of leakage and port being bent.Packaging was not an issue.
 
Event Description
It was reported that the 7-day ll vlv adpt(stand alone) experienced leakage.The following information was provided by the initial reporter: leaking and non functional.Iv bungs unable to use due to leaking and hard to connect the needle to it.No further details on when occurred and if product was attempted to be used or attached to a patients iv or seen to be faulty prior to use.Email sent to confirm sample availability, quantity affected and product code as document and email provided stated incorrect code 200037d however link in document referenced 2000e7d.Apologies the correct code is the 2000e7d.No issue with the packaging.Several reports of leakage and port being bent.Packaging was not an issue.
 
Manufacturer Narrative
H6: investigation summary no samples were received for investigation of complaint reference (b)(4); however the customer provided a photograph, which shows that the affected smartsite was bent and deformed.The details of this feedback were forwarded to the manufacturing site for investigation.The root cause of the distorted shape of the smartsite component is exposure to an external heat source that brings the component temperature above 60°c, if the smartsite is subjected to excessively high temperatures it is possible for the material to soften and deform; however a review of the manufacturing process, storage conditions and the sterilization process has not found a potential root cause for this level of excess heat.A review of the production records for lot 1017045 did not identify any in-process testing failures or quality deviations which may have caused or contributed to a report of this nature.A review of the customer feedback database indicates that this is a rare occurrence with a very small number of similar reports against the smartsite component; it is possible that there is a local environmental factor that has caused the product to reach the elevated temperature required to cause this issue (e.G.During storage or transit).See h.10.
 
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Brand Name
7-DAY LL VLV ADPT(STAND ALONE)
Type of Device
EXTENSION 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 Key10830570
MDR Text Key246955625
Report Number9616066-2020-20318
Device Sequence Number1
Product Code OJA
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 11/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/31/2023
Device Catalogue Number2000E7D
Device Lot Number1017045
Was Device Available for Evaluation? No
Date Manufacturer Received11/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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