FDA.reportPublic FDA data

MAUDE MDR 9733654

MDR report key
9733654
Report number
MW5093135
Event key
0
Event type
3
Date of event
2020-02-13
Date received
2020-02-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
109
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
1PAB MIXING CONTAINERCONTAINER, I.V.B BRAUN MEDICAL INC.KPEJ8J710 *
101---

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-190

Event Narratives#

D

Patient 1

WHILE MAKING AN IV SOLUTION WITHIN AN EMPTY PAB BAG, A FLOATER WAS NOTICED IN THE SOLUTION. THIS FLOATER APPEARED TO BE A PART OF THE BAG THAT HAD SOMEHOW GOTTEN DISLODGED OR BROKEN OFF DURING MANIPULATION. FDA SAFETY REPORT ID# (B)(4).