MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. NONVENTED PLUM SET 1'S; ADMINISTRATION SET

Model Number	1187912
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to return for investigation.It has not been received.
Event or Problem Description
The event involved a plumset that the customer reported had leakage on the connecting side of the filter and the tube during priming of taxol.There was no obvious defects noted on the tubing.The tubing was replaced and therapy resumed.There was no adverse event reported.
Additional Manufacturer Narrative
One used list number 118790412 - lifeshield latex-free h-p filter prim.I.V.Plumset, conv.Pin 104 inch w/prep inj site & ol, lot# 918695h was received for evaluation on 2/15/2019.The reported filter leak was confirmed by investigation.As received, the vent of the filter appeared wetted with infusate.The pressure applied and duration of use were not provided by the customer.A leak was observed from the outlet vent of the set.The leak appeared to seep through the vent material at numerous locations.The probable cause of the observed leak is temporary or permanent loss of the hydrophobic properties of the filter vent material due to infusate interactions.The exact cause has not been determined at this time.A batch record review was performed to lot# 918695h, list# 118790412 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 to 315 and 315 final sets, respectively with zero defects found.As a result no discrepancies that may have contributed to a complaint of this nature were found.

• Brand Name: NONVENTED PLUM SET 1'S
• Common Device Name: ADMINISTRATION SET
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 8286613
• Report Number: 9615050-2019-00018
• Device Sequence Number: 16642151
• Product Code: FRN
• UDI-Device Identifier: 10887787009023
• UDI-Public: (01)10887787009023(17)210701(10)918695H
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K982159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2019

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: 07/01/2021
• Device Model Number: 1187912
• Device Catalogue Number: 118790412
• Device Lot Number: 918695H
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/14/2019
• Supplement Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 04/03/2019
• 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: TAXOL, MFR UNKNOWN