FDA.reportPublic FDA data

MAUDE MDR 485425

MDR report key
485425
Report number
2518608-2003-00003
Event key
0
Event type
3
Date of event
2003-09-05
Date received
2003-09-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
COURTNEY SMITH
Address
P.O. BOX 80390 VALLEY FORGE PA 19484 US
Phone
610-610-6105
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1REUSABLE CATHETER PASSERCATHETER PASSERPHOENIX BIOMEDICALGBS*SP02K0701NYY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12003-09-1501. O

Event Narratives#

D

Patient 1

THE REUSABLE CATHETER PASSER IS A NON-STERILE STAINLESS STEEL INSTRUMENT. THE INSTRUCTION FOR USE IDENTIFIES THE PRODUCT AS NON-STERILE AND INDICATES THE STEAM STERILIZATION PROCEDURES. THE PRODUCT LABEL ALSO STATES THAT THE PRODUCT IS NON-STERILE. HOWEVER, THE LABEL USED, CAN BE USED FOR EO STERILIZATION. IT STATES "STERILE, EO", "STERILE UNLESS INNER PACKAGE IS OPEN OR DAMAGED" AND "INDICATOR DOT TURNS BROWN WHEN STERILE", ALTHOUGH THE EO INDICATOR DOT ON THE LABEL IS BLUE INDICATING THAT IT HAS NOT BEEN EXPOSED TO EO GAS. BECAUSE OF THE CONFLICTING STATEMENTS ON THE LABEL, STERILITY OF THE PRODUCT IS NOT CLEAR. AS A RESULT, NON-STERILE PRODUCT WAS USED ON A PT. THIS EVENT WAS DISCOVERED THE SAME DAY AND THE PT IS BEING TREATED WITH ANTIBIOTICS, AND INFECTION HAS NOT OCCURRED TO DATE.