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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD EXTENSION SET MICROBORE SLIDE CLAMP INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD EXTENSION SET MICROBORE SLIDE CLAMP INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number ME2020
Device Problems Complete Blockage (1094); Crack (1135); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/20/2022
Event Type  malfunction  
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Brand NameBD EXTENSION SET MICROBORE SLIDE CLAMP
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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15324242
Report Number9616066-2022-01247
Device Sequence Number1
Product Code FPA
UDI-Device Identifier20885403236256
UDI-Public20885403236256
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 Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/11/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberME2020
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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