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

Model Number 654301

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/29/2021

Event Type  malfunction  

Manufacturer Narrative

The device has been received for evaluation, however, investigation is not yet complete.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 286112922
• Report Number: 9615050-2022-00007
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10887787006725
• UDI-Public: (01)10887787006725(17)240701(10)5455555
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1