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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 EXT SET SMALLBORE .2MF PED INTRAVASCULAR ADMINISTRATION SET.

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD EXT SET SMALLBORE .2MF PED INTRAVASCULAR ADMINISTRATION SET. Back to Search Results
Catalog Number 10011865
Device Problems Fluid Leak (1250); Product Quality Problem (1506)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/12/2022
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. 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.
 
Event Description
It was reported when using the bd ext set smallbore. 2mf ped, the device experienced leakage. The following information was provided by the initial reporter. The customer stated: it was reported by customer that during a tubing change with inotropes, the tubing appeared to be leaking at the connection of the pall filter and the microbore tubing. During a tubing change with inotropes, the tubing appeared to be leaking at the connection of the pall filter and the microbore tubing. Per the rn it was hard to determine if this issue was at the filter or at the microbore tubing.
 
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Brand NameBD EXT SET SMALLBORE .2MF PED
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 Key13401194
MDR Text Key286924227
Report Number9616066-2022-00042
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K790108
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 02/03/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/31/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number10011865
Device Lot Number21079229
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/28/2021
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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