FDA.reportPublic FDA data

MAUDE MDR 8793284

MDR report key
8793284
Report number
9612030-2019-02217
Event key
0
Event type
3
Date received
2019-07-16
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
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
1GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORSCOVIDIENPIFPT00030482* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-07-1601. O

Event Narratives#

N

Patient 1

BRAND NAME IS UNKNOWN AT THIS TIME. EXACT PRODUCT CODE IS UNKNOWN AT THIS TIME. 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. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT.

D

Patient 1

THE CUSTOMER REPORTED THAT THE PATIENT HAD AN ENFIT NASOGASTRIC TUBE (NGT) PLACED FOR TUBE FEEDINGS WHILE INTUBATED AND SEDATED IN THE INTENSIVE CARE UNIT (ICU). THE PATIENT STARTED TO HAVE COFFEE GROUND EMESIS SO THE NGT WAS PLACED TO THE WALL SUCTION. ONLY A LIMITED AMOUNT CAME OUT AND THE PATIENT VOMITED AND ASPIRATED. THE PATIENT REQUIRED INTER-VENOUS (IV) ANTIBIOTICS AND A BRONCHOSCOPY. THE CUSTOMER STATED THERE WAS NO OBVIOUS SIGNS THAT THE TUBE WAS LEAKING OR THAT AN OCCLUSION OCCURRED.