FDA.reportPublic FDA data

MAUDE MDR 9889516

MDR report key
9889516
Report number
9612030-2020-02443
Event key
0
Event type
3
Date received
2020-03-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
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
508-508-5086
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PVC F TUBE 5FRX36IN W ENFITGASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORSCOVIDIENPIF461008E461008E* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-270

Event Narratives#

N

Patient 1

THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

D

Patient 1

THE CUSTOMER REPORTED THAT THE INFANT WAS RECEIVING NG TUBE FEEDING. UPON ASSESSMENT, THE RN NOTICED THAT THE CRIB SHEET WAS WET AND THERE WAS LEAKING AT THE HUB OF THE NG TUBE. UPON INSPECTION, THE NG TUBE HAD A CRACKED AT THE HUB. THE DEVICE WAS REMOVED AND PLACED WITH A NEW ONE. THERE WAS NO PATIENT INJURY.