FDA.reportPublic FDA data

MAUDE MDR 6633865

MDR report key
6633865
Report number
6633865
Event key
0
Event type
3
Date of event
2017-05-23
Date received
2017-05-31
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
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NIPRO SAFE TOUCH IINIPRO FISTULA NEEDLE 15GNIPROFIEFS-152530BC16C16I N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-05-3101. O; 2. R

Event Narratives#

D

Patient 1

CCHT NOTED THAT THERE WERE A LOT OF AIR IN THE LINE. STOPPED TREATMENT TO RECIRCULATE LINES TO REMOVE THE AIR BUBBLES. RESUMED TREATMENT AFTER REMOVING THE AIR BUT NOTICED THAT THERE WAS A LOT OF BLOOD LEAKING AROUND THE ARTERIAL NEEDLE SITE WHEN SHE RESTARTED TREATMENT AND WAS UNABLE TO CONTROL THE BLEEDING.