FDA.reportPublic FDA data

MAUDE MDR 1942693

MDR report key
1942693
Report number
6000001-2010-06420
Event key
0
Event type
3
Date of event
2010-03-01
Date received
2010-12-30
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
KAREN KIRBY
Address
25212 W. ILLINOIS ROUTE 120 ROUND LAKE IL 60073 US
Phone
847-847-8472
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VITALHOLD STD BORE EXTSET W/VLCATHETER SECUREMENT (CONVENIENCE KIT)INTRAVENOUS EXTENSION TUBING SETBAXTER HEALTHCAREOJA6N8220R R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-12-300

Event Narratives#

D

Patient 1

THE CUSTOMER REPORTED TO BAXTER (B)(4) A VITALHOLD STANDARD BORE EXTENSION SET WITH V-LINK CATHETER SECUREMENT (CONVENIENCE KIT) THAT WOULD NOT ALLOW FLOW THROUGH THE V-LINK AFTER THE SOLUTION BAG WAS SPIKED. THE CUSTOMER WAS USING A CONTINU-FLO 109" INCH PRIMARY SET IN CONJUNCTION WITH THE V-LINK EXTENSION SET. THE CONDITION OCCURRED DURING PRIMING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE.

N

Patient 1

(B)(4). THE CUSTOMER SENT IN FIVE USED SAMPLES FOR EVALUATION. ALL SAMPLES WERE ATTACHED TO AN IN-HOUSE PRIMARY SET WHICH WAS SPIKED INTO A 1000ML SOLUTION BAG CONTAINING REVERSE OSMOSIS WATER. SAMPLES 1-4 PRIMED NORMALLY WITH NORMAL FLOW NOTED. HOWEVER, SAMPLE 5 WOULD NOT PRIME. A VISUAL INSPECTION UNDER A MICROSCOPE OF THE GLAND ON SAMPLE 5 REVEALED A RE-KNIT CONDITION OF THE CENTER SLIT. BASED ON THE EVALUATION RESULTS THE CONDITION WAS CONFIRMED. THIS CONDITION WAS CAUSED BY RE-KNIT OF THE CENTER SLIT. THERE IS NO 510K NUMBER ASSOCIATED WITH THIS PRODUCT AS IT IS 510K EXEMPT. HOWEVER, THE INDIVIDUAL COMPONENT FROM THE KIT WITH THE REPORTED DEFECT HAS A 510K NUMBER. THEREFORE, IN THIS MDR, THE 510K NUMBER UTILIZED IS REFERRING TO THE SPECIFIC COMPONENT OF THE KIT RELATING TO THE REPORTED CONDITION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.