MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. LTXFR NV TUR Y-SET; CATHETER, IRRIGATION

Model Number	654301
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation, however, investigation is not yet complete.
Event or Problem Description
It was reported that an eyelash was identified in the bladder irrigation tubing of a ltxfr nv tur y-set.The package was sealed prior to the customer finding the eyelash.There was no patient involvement, no adverse event and no harm.
Additional Manufacturer Narrative
One new list number 065430403, t-u-r y-set, nonvented, 96 inch; lot number 5455555.The complaint of hair in the tubing/fluid path could not be confirmed on the one returned unit, however, hair was observed inside the packaging of the returned unit.No other anomalies or damages were observed.The probable cause is due to an error during gowning at the manufacturing site.Lot history review was performed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: LTXFR NV TUR Y-SET
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 13265971
• Report Number: 9615050-2022-00007
• Device Sequence Number: 5236026
• Product Code: GBX
• UDI-Device Identifier: 10887787006725
• UDI-Public: (01)10887787006725(17)240701(10)5455555
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2024
• Device Model Number: 654301
• Device Catalogue Number: 065430403
• Device Lot Number: 5455555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2022
• Supplement Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 01/17/2022
• Supplement Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown