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	03/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has returned for evaluation.Investigation is not complete.Pma/510(k) - exempt.
Event or Problem Description
The event involved an irrigation set, large bore, tur, urological connector 96 inch, that when puncturing the iv bag, pieces of the spike were seen floating in the sight chamber.The device was replaced and therapy was resumed.There was no adverse event and no delay in critical therapy.
Additional Manufacturer Narrative
Received one used latex-free nonvented t-u-r y-set lot#856405h for evaluation.As received, the piercing pins were found to be broken.Examination of the piercing pin surfaces shows evidence of twisting or bending forces exerted on the window bases.This effect was able to be replicated by using an intact irrigation set piercing pin (same list number) to access a new flexible container of water.During this test, the pin was able to be pushed through the diaphragm with no problems and flow was established.However if the pin was pushed partially through the diaphragm, then bent, the tip of the piercing pin snapped off.This break does not occur if the bag/pin connection is torqued on or bent after the pin has been completely inserted into the bag.The complaint of the piercing pins being brittle cannot be confirmed.The customer complaint of piercing pins breaking during use can be confirmed.The probable cause of the breaks is unintentional bending forces exerted on the piercing pin during insertion of the pin into a new flexible container of fluid.A batch record review was performed to lot# 856405h, list# 06543-0403 and no discrepancies that may have contributed to a complaint of this nature were found.The quality inspection of final visual and physical evaluation results indicated that the product met specification requirements.Manufacturing quality (mq) performed visual and physical evaluation with zero defects found.No process changes, unusual event, re-work, re-processing or re-inspection activities were generated or performed to the batch mentioned above or its commodities.As a result no discrepancies that may have contributed to a complaint of this nature were 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: 8561689
• Report Number: 9615050-2019-00131
• Device Sequence Number: 16730923
• Product Code: GBX
• UDI-Device Identifier: 10887787006725
• UDI-Public: (01)10887787006725(17)210131(10)856405H
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2019

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: 01/31/2021
• Device Model Number: 654301
• Device Catalogue Number: 065430403
• Device Lot Number: 856405H
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/19/2019
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 04/29/2019
• Supplement Report FDA Received Date: 05/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1