FDA.reportPublic FDA data

MAUDE MDR 2988922

MDR report key
2988922
Report number
1018233-2013-00537
Event key
0
Event type
3
Date of event
2013-01-24
Date received
2013-02-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
KIM SHIRAH
Address
8195 INDUSTRIAL BOULEVARD COVINGTON GA 30014 US
Phone
770-770-7707
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HEMATURIA 3-WAY 30CC LUBBARD SDN. BHD.KODNA2551H22MYWHR299R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-02-2501. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT THE PACKAGING FOR A ROUND TIP CATHETER, (B)(4), ACTUALLY CONTAINED A CATHETER WITH A COUVELAIRE TIP (POSSIBLY (B)(4)). EITHER THE WRONG CATHETER WAS IN THE PACKAGE, OR A WRONG PACKAGE NUMBER WAS ON THE OUTSIDE OF THE PACKAGE. THE DOCTOR WAS PLACING THE CATHETER WITH A STYLET AND HE DID NOT SEE THAT IT WAS A DIFFERENT CATHETER. THE STYLET WENT THROUGH THE COUVELAIRE TIP AND CAUSED ADD'L BLEEDING IN THE BLADDER. THE OPERATING ROOM ASSISTANT PLACED THE STYLET INTO THE CATHETER. ADD'L INFO HAS BEEN REQUESTED BUT NOT YET REC'D.

N

Patient 1

INVESTIGATION OF THIS EVENT IS STILL IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED UPON COMPLETION.