FDA.reportPublic FDA data

MAUDE MDR 879043

MDR report key
879043
Report number
3031042-2006-00044
Event key
0
Event type
3
Date of event
2006-08-18
Date received
2006-09-15
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
SALLY HERRICK
Address
1400 HOLCOMB BRIDGE RD 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/ BALLARDBYHNA131354907NNR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12006-09-150

Event Narratives#

D

Patient 1

AN INCIDENT REPORT WAS RECEIVED THROUGH THE KIMBERLY-CLARK SALES REP ON BEHALF OF THE USER FACILITY. THE SAFETY DRAIN DEVICES HAD LEAKS AT THE SUCTION PORT AND CAUSED PRESSURE LOSS. ONE PT WENT INTO BRADYCARDIA WITH PEEP (POSITIVE END EXPIRATORY PRESSURE) OF 18 AND FIO2 AT 80 PERCENT. THE PT WAS REMOVED FROM THE VENTILATOR AND HAND BAGGED UNTIL THE SAFETY DRAIN COULD BE REPLACED. DURING THAT TIME, THE VENTILATOR WAS INOPERATIVE. ADD'L INCIDENT RELATED PT MEDICAL PROBLEMS OR OTHER PT ISSUES WERE NOT CITED. KIMBERLY-CLARK OR BALLARD MEDICAL HAS NO FIRST HAND KNOWLEDGE OF THE ALLEGATIONS BUT IS RELAYING INFO RECEIVED FROM OUTSIDE SOURCES PURSUANT TO FEDERAL REGULATIONS.

N

Patient 1

THE MANUFACTURE OF THIS PRODUCT LINE IS IN THE PROCESS OF BEING RELOCATED, ALONG WITH THE ASSOCIATED TESTING EQUIPMENT. UNTIL THE EQUIPMENT IS VALIDATED AND THE RETURNED DEVICES CAN BE THOROUGHLY TESTED, NO CONCLUSION CAN BE DRAWN AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE FILED WITH THE TEST RESULTS WHEN THE EVALUATIONS HAVE BEEN COMPLETED.