FDA.reportPublic FDA data

MAUDE MDR 7365207

MDR report key
7365207
Report number
MW5075996
Event key
0
Event type
3
Date of event
2018-03-21
Date received
2018-03-22
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#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CORPAKFEEDING TUBEMEDSYSTEMS/ SEISA MEDICAL INC.FPD20-9368TRAK2I Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-03-2201. R

Event Narratives#

D

Patient 1

SIZE 8 FR FEEDING TUBE INSERTED WITH NO RESISTANCE, WIRE PULLED OUT WITH NO KINKS WHEN PLACEMENT CHECKED WITH SYRINGE, UNABLE TO PUSH ANY AIR THROUGH, PATIENT IN NO DISTRESS, TUBE WAS PULLED BACK TO CHECK NO CHANGES, PATIENT IN NO DISTRESS, PUSHED BACK IN UNABLE TO PUSH ANY AIR THROUGH. TUBE PULLED BACK COMPLETELY, NO AIR ABLE TO PUSH THROUGH THE FIRST TIME (TUBE WAS ALREADY OUTSIDE THE PATIENT) ATTEMPTED TWO MORE TIMES THEN ON THE THIRD TIME, FINALLY ABLE TO PUSH THROUGH AIR IN THE TUBE. BRAND NAME WAS CORPACK NEW TUBE WAS INSERTED WITH NO PROBLEMS, AND PLACEMENT CHECK.