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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. LTXFR NV TUR Y-SET; ADMINISTRATION SET
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ICU MEDICAL COSTA RICA LTD. LTXFR NV TUR Y-SET; ADMINISTRATION SET Back to Search Results
Model Number 654301
Device Problem Particulates (1451)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/13/2019
Event Type  malfunction  
Manufacturer Narrative
The customer indicated that the device is not available for investigation.
 
Event Description
Icu medical received a user facility medwatch (#mw5086789) stating that when changing the t-u-r tubing, the spike tip broke into pieces during bladder irrigation.There was no harm to the patient and no medical intervention was required.
 
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Brand Name
LTXFR NV TUR Y-SET
Type of Device
ADMINISTRATION SET
Manufacturer (Section D)
ICU MEDICAL COSTA RICA LTD.
zona franca global
la aurora heredia
CS 
Manufacturer Contact
emily arnould, bsn, rn
600 n. field dr.
lake forest, IL 60045
2247062300
MDR Report Key8705391
MDR Text Key148302429
Report Number9615050-2019-00192
Device Sequence Number1
Product Code GBX
UDI-Device Identifier10887787006725
UDI-Public(01)10887787006725(17)220101(10)3895537
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Nurse
Type of Report Initial
Report Date 06/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/01/2022
Device Model Number654301
Device Catalogue Number065430403
Device Lot Number3895537
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/03/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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