FDA.reportPublic FDA data

MAUDE MDR 1363070

MDR report key
1363070
Report number
1018233-2006-00086
Event key
0
Event type
3
Date of event
2006-02-20
Date received
2006-05-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
VIVIAN STEPHENS, MGR
Address
8195 INDUSTRIAL BLVD. COVINGTON GA 30014 US
Phone
770-770-7707
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BARD NASOGASTRIC SUMP TUBENASOGASTRIC SUMP TUBEC.R. BARD, INC.FEGNA0046140UNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12006-05-0901. R

Event Narratives#

D

Patient 1

ADDITIONAL TEXT FROM USER FACILITY REPORT: # 14 NG TUBE PLACED IN LEFT NARE IN THE ED. CT CONTRAST ADMINISTERED VIA TUBE AT 2300. PT TO X-RAY - COMPLAINED OF TUBE DISCOMFORT - UNABLE TO VERIFY PLACEMENT - TUBE REMOVED. BREATH SOUNDS WERE DIMINISHED. PT EXPERIENCED RUPTURED ESOPHAGUS AND PNEUMO-THORAX. NEW PRODUCT FOUND TO BE RIGID, CAUSING FREQUENT NASAL TRAUMA AND BLEEDING AND INCREASED DISCOMFORT.

N

Patient 1

NO SAMPLE OR LOT NUMBER INFO WAS PROVIDED FOR EVAL. THE NG TUBE IS MADE OF A STIFF PVC MATERIAL WHICH SOFTENS WHILE INDWELLING AND IS DESIGNED TO SUCTION FLUID AND AIR FROM THE STOMACH WITHOUT DAMAGING THE GASTRIC MUCOSA. THE TUBE WAS INSERTED IN THE EMERGENCY DEPARTMENT AND IT IS NOT KNOWN IF TIME ALLOWED ADHERENCE TO LABELING INSTRUCTIONS AND HOSPITAL PROTOCOL. THE INSTRUCTIONS FOR USE STATE TO LUBRICATE THE TUBE PRIOR TO INSERTION. A NOTE STATE: "TO CONFIRM PROPER PLACEMENT OF THE NASOGASTRIC SUMP TUBE, PERFORM THE FOLLOWING: RAPIDLY INJECT APPROXIMATELY 10-20CC OF AIR THROUGH THE BLUE AIR VENT WHILE AUSCULATING THE ABDOMEN. THE RUSH OF AIR AS IT ENTERS THE STOMACH WILL BE HEARD IF THE TUBE IS CORRECTLY PLACED. ASPIRATE GENTLY TO OBTAIN STOMACH CONTENTS. X-RAYS MAY BE DONE TO CONFIRM PROPER PLACEMENT". THE REPORTER STATED "THEY WERE UNABLE TO DETERMINE IF ISSUE WAS RELATED TO USER TECHNIQUE OR PRODUCT". THIS ISSUE IS MORE LIKELY THE RESULT OF AN UNANTICIPATED PROCEDURAL COMPLICATION THAN ANY KNOWN DEFECT IN THE PRODUCT. BASELINE REPORT PREVIOUSLY FILED. CORRECTIONS TO USER FACILITY MEDWATCH REPORT MADE IN PRING IN BLUE INK ON THIS FORM. ADDITIONAL INFORMATION FROM THE USER FACILITY REPORT: 2006, C.R. BARD. #14 FR NG TUBE.