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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GEM V/NV CKV 3 SS 20DP 20PK INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GEM V/NV CKV 3 SS 20DP 20PK INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 2426-0500
Device Problem Leak/Splash (1354)
Patient Problem No Patient Involvement (2645)
Event Date 12/02/2020
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. Fda device problem code(s): 1354, fda patient problem code(s): 2645.
 
Event Description
It was reported that the gem v/nv ckv 3 ss 20dp 20pk experienced component separation. The following information was provided by the initial reporter: complaint 1 of 2 material #: 2426-0500 batch/ lot #: 20073206 the nurse took the package off the shelf and opened the package and a part of the iv tubing fell on the floor because it was not connected to the tubing.
 
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Brand NameGEM V/NV CKV 3 SS 20DP 20PK
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 Key11103500
MDR Text Key224796771
Report Number9616066-2020-20710
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K944320
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 02/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2426-0500
Device Lot Number20073206
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/02/2020
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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