MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 8.5" (22 CM) APPX 1.0 ML, EXT SET W/MICROCLAVE CLEAR, CHEMOLOCK PORT, SPIROS; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number	CL3931
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One used sample was received for evaluation with various mating devices.As received, no visible damage or anomalies were identified on any of the returned devices.The used sample was leak tested and leakage occurred at the interface between the post of the chemolock port and the bond pocket of the y-connector.The reported complaint can be confirmed.The probable cause of the leak was due to an inadequate luer insertion during the manual assembly process.The lot review was performed and there were no issues found.
Event or Problem Description
The customer reported that 8.5" (22 cm) appx 1.0 ml, ext set w/microclave® clear, chemolock¿ port, spiros® w/red cap leaked chemotherapy.It was further described that after chemotherapy finished, there was a wet liquid noticed around the chemolock port from the backside of port.This occurred during patient use after an hour after the start.The patient was washed and the bed was changed.The chemo spill was cleaned up as per facility protocol.There was a minimal loss, that was found straight away and the extension set was replaced.The tubing was set up with standard setup saline line and chemo line in the extension set in respective ports, there was no blood loss or bleed back.There was no adverse event and no harm as a result of the event.

• Brand Name: 8.5" (22 CM) APPX 1.0 ML, EXT SET W/MICROCLAVE CLEAR, CHEMOLOCK PORT, SPIROS
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 10146169
• Report Number: 9617594-2020-00173
• Device Sequence Number: 2438466
• Product Code: ONB
• UDI-Device Identifier: 00887709077201
• UDI-Public: (01)00887709077201(17)240701(10)4172961
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K131549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/18/2020

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: CL3931
• Device Catalogue Number: CL3931
• Device Lot Number: 4172961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 06/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1