FDA.reportPublic FDA data

MAUDE MDR 854617

MDR report key
854617
Report number
9611594-2006-00052
Event key
0
Event type
3
Date of event
2006-09-12
Date received
2006-10-11
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
SALLY HERRICK
Address
1400 HOLCOMB BRIDGE ROAD ROSWELL GA 30076 US
Phone
770-770-7705
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SAFETY DRAINDRAIN, TEE (WATER TRAP)KIMBERLY-CLARK / AVENTBYHNA131*NYR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12006-10-1101. O

Event Narratives#

D

Patient 1

AN INCIDENT REPORT WAS RECEIVED THROUGH THE KIMBERLY-CLARK SALES REPRESENTATIVE ON BEHALF OF THE USER FACILITY. THE VALVE OF THE SAFETY DRAIN DEVICE DID NOT CLOSE PROPERLY. FLUID SPRAYED THE EYES OF TWO EMPLOYEES. INFORMATION FROM THE USER FACILITY STATED THAT THE DRAIN VALVE OF THE SAFETY DRAIN DEVICE WAS STICKING OPEN AND WATER SPEWING OUT IF IT AS WELL AS AIR FROM THE VENTILATOR LEAKING OUT. THE USER ATTEMPTED TO USE A SUCTION DEVICE TO UNSTICK THE VALVE. THIS DID NOT WORK AND THE USER WAS SPRAYED IN THE FACE. THE SAFETY DRAIN DEVICE WAS REPLACED WITH A NEW ONE BUT THE USER HAD TO BREAK THE VENTILATORY CIRCUIT TO DO SO. THE USER CONSIDERED THIS ACTION TO BE INCREASED RISK OF POSSIBLE VENTILATOR ASSOCIATED INFECTION TO THE PATIENT. THE EMPLOYEES THAT WERE SPLASHED WENT TO THE EMPLOYEE HEALTH AND FLUSHED THEIR EYES WITH WATER. NO ADDITIONAL TREATMENT WAS DONE AND THE EMPLOYEES HAD NO RESIDUAL EFFECTS. KIMBERLY-CLARK OR BALLARD MEDICAL HAS NO FIRST HAND KNOWLEDGE OF THE ALLEGATIONS BUT IS RELAYING INFORMATION RECEIVED FROM OUTSIDE SOURCES PURSUANT TO FEDERAL REGULATIONS.

N

Patient 1

THE RETURNED DEVICE WAS VISUALLY EXAMINED AND PERFORMANCE TESTED. THE DEVICE MALFUNCTIONED AS THE PORT SEAL OPENED. WATER IN THE CUP PORTION OF THE DEVICE WAS ABLE TO COME UP THROUGH THE PICK-UP TUBE AND OUT THE PORT SEAL OPENING, EXITING THE CUP. AN INTERNAL INVESTIGATION IS BEING CONDUCTED TO DETERMINE THE ROOT CAUSE. INPUT FROM A RESPIRATORY THERAPIST CONSULTANT STATED THAT IF UNIVERSAL PRECAUTIONS HAD BEEN FOLLOWED, SPRAYING OF THE EYES WOULD NOT HAVE OCCURRED.