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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 18FR SALEM W/ GIENTRI PORT WIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
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COVIDIEN 18FR SALEM W/ GIENTRI PORT WIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS Back to Search Results
Model Number 7771810E
Medical Device Problem Codes Decrease in Suction (1146); Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
 
Event or Problem Description
The customer reported the patient¿s multifunctional port was leaking.It was replaced and seemed to do better with suctioning, but had to be manipulated in the beginning before it started working well.There was no harm to the patient.
 
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Brand Name
18FR SALEM W/ GIENTRI PORT WIT
Common Device Name
GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
Manufacturer (Section D)
COVIDIEN
calle 9 sur no. 125 cuidad ind
tijuana 22500
MX  22500
MDR Report Key10627929
Report Number9612030-2020-02640
Device Sequence Number2604182
Product Code PIF
UDI-Device Identifier10884521582743
UDI-Public10884521582743
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Model Number7771810E
Device Catalogue Number7771810E
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/09/2020
Initial Report FDA Received Date10/05/2020
Patient Sequence Number1
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