16FR SALEM W/ GIENTRI PORT WIT 7771610E

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-03 for 16FR SALEM W/ GIENTRI PORT WIT 7771610E manufactured by Covidien.

Event Text Entries

[181949671] 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.
Patient Sequence No: 1, Text Type: N, H10


[181949672] The customer reported that the tip of the feeding tube formed a "c" shape and seemed to kink on itself. They tried to administer feed, but it would not go through. They removed the device and replaced it with a feeding tube from another manufacturer. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9612030-2020-02430
MDR Report Key9779927
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-03-03
Date of Report2020-03-03
Date of Event2020-02-25
Date Mfgr Received2020-02-25
Date Added to Maude2020-03-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJILL SARAIVA
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5086183640
Manufacturer G1COVIDIEN
Manufacturer StreetCALLE 9 SUR NO 125 CUIDAD IND
Manufacturer CityTIJUANA 22500
Manufacturer CountryMX
Manufacturer Postal Code22500
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name16FR SALEM W/ GIENTRI PORT WIT
Generic NameGASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
Product CodePIF
Date Received2020-03-03
Model Number7771610E
Catalog Number7771610E
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer AddressCALLE 9 SUR NO. 125 CUIDAD IND TIJUANA 22500 MX 22500


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-03

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