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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 20D 1CV 2SS DEHP FREE INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GEM V/NV 20D 1CV 2SS DEHP FREE INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 2420-0007
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/23/2020
Event Type  malfunction  
Manufacturer Narrative
Date of birth: only the patient's age was provided, therefore a default date of birth has been listed. Medical device expiration date: na. Fda notified: the initial reporter also notified the fda on (date) via medwatch # (b)(4). 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 gem v/nv 20d 1cv 2ss dehp free experienced component separation and leakage. The following information was provided by the initial reporter: material #: 2420-0007; batch/ lot #: 20093112. Patient rang out and nurse answered bell. Patient found to have a large pool of blood on the floor approximately loomls. Upon investigation patient's tubing was found to have broken. Tubing was not broken at a connection or cap placement site. Tubing broke right in the middle of the line as it were cut. Tubing taken to clinical science laboratory to be photographed for patient safety. Upon patient interview, patient did not feel at any point his tubing was tight or was pulling. Medical team notified. No intervention needed.
 
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Brand NameGEM V/NV 20D 1CV 2SS DEHP FREE
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 Key11103424
MDR Text Key225825773
Report Number9616066-2020-20707
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 01/18/2021
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 Number2420-0007
Device Lot Number20093112
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 Received01/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/28/2020
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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