FDA.reportPublic FDA data

MAUDE MDR 8569784

MDR report key
8569784
Report number
9612030-2019-02163
Event key
0
Event type
3
Date of event
2019-04-17
Date received
2019-05-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
JILL SARAIVA
Address
15 HAMPSHIRE STREET MANSFIELD MA 02048 US
Phone
508-508-5084
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
118FR SALEM W/ GIENTRI PORT WITGASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORSCOVIDIENPIF7771810E7771810E* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-05-010

Event Narratives#

N

Patient 1

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.

D

Patient 1

THE CUSTOMER REPORTS THE PATIENT'S SALEM SUMP TUBE WAS HOOKED TO THE WALL SUCTION, SET TO LOW INTERMITTENT SUCTION. THE OUTPUT WAS LOW; HOWEVER, THERE'S BILIOUS OUTPUT IN THE TUBING AND AFTER 3 HOURS THE PATIENT HAD A BILIOUS EMESIS, ZOFRAN WAS ADMINISTERED RIGHT AWAY. THE NURSING STAFF STARTED TROUBLE SHOOTING AND CHECKED THE WALL SUCTION WHICH WAS FUNCTIONING PROPERLY. THE NURSES CHECKED THE TUBE AND ADAPTER AND FOUND IT WAS FLUSHING FINE AND THE ARROW AND SETTING WAS WHERE IT WAS SUPPOSED TO BE. A NEW ADAPTER WAS TRIED WITH NO IMPROVEMENT. AN X-RAY CONFIRMED THAT THE TUBE WAS IN THE CORRECT PLACE. THE PATIENT WASN'T IN DISTRESS; SHE WAS COMFORTABLE AFTER THE EMESIS EPISODE. HOWEVER, HOURS LATER, WHEN THE NURSES STOOD THE PATIENT UP AT BEDSIDE, SHE HAD HER 2ND EPISODE OF BILE EMESIS.