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

Model Number	654301
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and is pending evaluation.Pma/510(k): exempt.
Event or Problem Description
The customer reported that while using an irrigation set, pieces of the spike broke off into irrigation bag.This occurred during bladder irrigation on a patient.The was no harm reported.It was further described that the customer spiked a 3000l of normal saline and that is when the piece broke off.
Additional Manufacturer Narrative
Two irrigation sets were received for investigation.On one set, one of the bag spike tips is observed to be broken off at the bottom of the spike windows.The broken tip was not returned for investigation.On the second set, both bag spike tips are observed to be broken off at the bottom of the spike windows.The broken tips were not returned for investigation.A dimensional analysis was completed for the returned intact bag spike and the spike met all dimensional specifications.The observed broken tip damage was recreated by inserting the tip of the returned intact bag spike into a lab provided iv bag and applying a bending force.The probable cause of the observed breaks is excessive bending force at the spike tips during spike insertion.Lot review was performed and there were no issues found.

• Brand Name: LTXFR NV TUR Y-SET
• Common Device Name: ADMINISTRATION SET
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 8479888
• Report Number: 9615050-2019-00098
• Device Sequence Number: 13820985
• Product Code: GBX
• UDI-Device Identifier: 10887787006725
• UDI-Public: (01)10887787006725(17)210801(10)925625H
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2019

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: 08/01/2021
• Device Model Number: 654301
• Device Catalogue Number: 065430403
• Device Lot Number: 925625H
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/13/2019
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NORMAL SALINE