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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 60-IN STANDARDBORE EXT SET INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 60-IN STANDARDBORE EXT SET INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number ME2068
Device Problem Component Missing (2306)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/15/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter zip: (b)(6). Investigation summary: a complaint of a set not being assembled with clamps was received from the customer. One unopened sample was received from the customer. Through visual inspection, the customer complaint was not confirmed. No clamps were present on the set. However this set is not manufactured with clamps per the assembly drawing. No other defects/ damages observed. A device history record review for model me2068 lot number 20066073 was performed. The search showed that a total of (b)(4) units in 1 lot number was built on 23jun2020. There were no quality notifications issued for the failure mode reported by the customer during the production build of this set. A root cause could not be determined as there was no defect on the product. This incident has been added to our database of reported incidents. Our business team regularly reviews the collected data for identification of emerging trends. A root cause could not be determined as there was no defect on the product.
 
Event Description
It was reported that the 60-in standardbore ext set experienced a missing roller clamp. The following information was provided by the initial reporter: sets did not come with clamps.
 
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Brand Name60-IN STANDARDBORE EXT SET
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
Manufacturer (Section G)
SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
blvd. insurgentes no. 20351
parque industrial el florido
tijuana
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12173240
MDR Text Key261724064
Report Number9616066-2021-51513
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051499
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberME2068
Device Catalogue NumberME2068
Device Lot Number20066073
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/10/2020
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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