FDA.reportPublic FDA data

MAUDE MDR 226048

MDR report key
226048
Report number
6000002-1999-00166
Event key
0
Event type
3
Date of event
1999-05-07
Date received
1999-06-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ADVANCED VENOUS ACCESS CATHETERCENTRAL VENOUS ACCESS CATHETERBAXTER HEALTHCARE CORP.JCYM3L9FHKNAUNKK981909NRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11999-06-0401. D

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT A PT WAS ADMITTED WITH SEVERE SEPTIC SHOCK. IT WAS STATED THAT THE CATHETER WAS INSERTED AND RESISTANCE WAS NOTED. FLUID WAS INFUSED THROUGH THE LINE. AN X-RAY WAS TAKEN AND THE CATHETER WAS REPOSITIONED. IT WAS REPORTED THAT A PNEUMOTHORAX OCCURRED; THE PT CODED AND EXPIRED. FOLLOWUP WITH THE PHYSICIAN INDICATED THAT THE REPORT IS NOT ATTRIBUTED TO THE CATHETER PER SE, HOWEVER MORE SECONDARY TO THE PT'S SUBCUTANEOUS CONDITION. NO AUTOPSY WAS PERFORMED.