FDA.reportPublic FDA data

MAUDE MDR 9868484

MDR report key
9868484
Report number
1416980-2020-01657
Event key
0
Event type
3
Date of event
2020-02-27
Date received
2020-03-23
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Address
25212 W. ILLINOIS ROUTE 120 ROUND LAKE IL 60073 US
Phone
224-224-2242
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TUBE SET, STD VOL, STERSET, I.V. FLUID TRANSFERBAXTER HEALTHCARE CORPORATIONLHINAH9381160188266R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-230

Event Narratives#

N

Patient 1

SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

D

Patient 1

IT WAS REPORTED THAT THE WHITE SPIKE END OF A STERILE REPEATER PUMP TUBE SET SEPARATED FROM THE TUBING AND CAUSED A LEAK; THIS WAS FURTHER DESCRIBED BY THE REPORTER AS ?WE SPIKE OUR BAG, AND THEN WE PUT ON THE COMPOUNDER AND THEN PRIME TUBING AND THEN WITHIN SECONDS OF PRIMING THE TUBING SPIKE BECOMES LOOSE AND THE LIQUID SPILLS?. THIS ISSUE WAS IDENTIFIED DURING COMPOUNDING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

N

Patient 1

ADDITIONAL INFORMATION WAS ADDED: THE LOT WAS MANUFACTURED FORM JUNE 10, 2019 - JUNE 12, 2019. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. UNAIDED VISUAL INSPECTION WAS PERFORMED WHICH OBSERVED THAT THE TUBE SET SPIKE WAS DETACHED FROM THE TUBE SET TUBING. BECAUSE THE TUBE SET WAS RECEIVED DAMAGED, FUNCTIONAL TESTING COULD NOT BE PERFORMED. PER VISUAL INSPECTION, THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED, HOWEVER, A LIKELY CAUSE WOULD BE INADEQUATE OR LACK OF ADHESIVE BEING APPLIED AT THE BASE OF THE SPIKE TO THE TUBE SET TUBING IN THE MANUFACTURING PROCESS. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.