FDA.reportPublic FDA data

MAUDE MDR 9587589

MDR report key
9587589
Report number
1416980-2019-07553
Event key
0
Event type
3
Date of event
2019-10-31
Date received
2020-01-14
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
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
1CYSTOSCOPY IRRIGATION SETSYSTEM, IRRIGATION, UROLOGICALBAXTER HEALTHCARE CORPORATIONLJHNA2C4040ASKUY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-140

Event Narratives#

N

Patient 1

(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

D

Patient 1

IT WAS REPORTED APPROXIMATELY NINETEEN CYSTO/BLADDER IRRIGATION SETS WERE CONTAMINATED. IT WAS FURTHER REPORTED THAT THE INSIDE OF THE TUBING APPEARED DISCOLORED, WITH "GREY/BLACK BLOTCHES". THIS EVENT WAS DISCOVERED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

N

Patient 1

ADDITIONAL INFORMATION WAS ADDED. ONE SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO PARTICULATE MATTER WAS OBSERVED ON THE TUBING; HOWEVER, A DISCOLORATION WAS OBSERVED BETWEEN THE WALLS OF THE TUBING, THAT WOULD CAUSE A VISUAL EFFECT OF CONTAMINATION ON THE TUBING. THE REPORTED CONDITION WAS NOT VERIFIED. THE OTHER SAMPLES WERE NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.