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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.
 
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Brand Name7-DAY LL VLV ADPT(STAND ALONE)
Type of DeviceEXTENSION 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 Key10830570
MDR Text Key246955625
Report Number9616066-2020-20318
Device Sequence Number1
Product Code OJA
Combination Product (y/n)N
Reporter Country CodeAS
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 11/20/2020
1 Device was Involved in the Event
0 Patients were 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 Catalogue Number2000E7D
Device Lot Number1017045
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/11/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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