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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) INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 7-DAY LL VLV ADPT(STAND ALONE) INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 2000E7D
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Patient Involvement (2645)
Event Date 12/03/2020
Event Type  malfunction  
Manufacturer Narrative
The date received by manufacturer has been used for this field. 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 barcode/ean number on the 7-day ll vlv adpt(stand alone) box did not match the registered one. The following information was provided by the initial reporter, translated from (b)(6) to english: "the barcode on the product box does not match the registered one. Consumer sent photo with the correct barcode and the incorrect barcode". "customer is complaining about the ean number. Once in the past they received the product with ean code: (b)(4) and now the same product with ean (b)(4). " "customer informed - it is due to the divergence in the bar code, as i have (b)(4) in stock and (b)(4) was sent in this invoice, with this, we are not able to continue with the entry of the item in our stock because it conflicts with the previous registration. ".
 
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Brand Name7-DAY LL VLV ADPT(STAND ALONE)
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 Key11103532
MDR Text Key251100895
Report Number9616066-2020-20715
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2000E7D
Device Lot Number1017152
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 Received01/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/25/2020
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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