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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C. GEM 20DP NO PORTS 0.2MF INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C. GEM 20DP NO PORTS 0.2MF INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 11612593
Device Problem Leak/Splash (1354)
Patient Problem No Patient Involvement (2645)
Event Date 05/18/2020
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.

 
Event Description

It was reported that an unspecified number of gem 20dp no ports 0. 2mf experienced defective/damaged tubing clamps and loose tubing clamps. The following information was provided by the initial reporter: when rn opened the package for the tubing, the clamp roller fell out on the floor. Upon closer inspection, the top piece of the clamp was broken, allowing the roller to fall out customer response to information request 15 jun 2020: was there any patient involvement? no. Was anyone injured and were any interventions needed? no.

 
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Brand NameGEM 20DP NO PORTS 0.2MF
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
SISTEMAS MEDICOS ALARIS, S.A. DE C.
blvd. insurgentes 20351
tijuana, null 22244
MX 22244
Manufacturer (Section G)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 s state st
sandy UT 84070 3213
Manufacturer Contact
brett wilko
9450 s state st
sandy, UT 84070-3213
8015652341
MDR Report Key10216200
MDR Text Key198700242
Report Number9616066-2020-02058
Device Sequence Number1
Product Code FPA
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK894842
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial
Report Date 06/09/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/30/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL Number11612593
Device Catalogue NumberUNKNOWN
Device LOT Number10885403283963
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured03/05/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/30/2020 Patient Sequence Number: 1
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