MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 60ML SYRINGE W/SPINNING SPIROS®, RED CAP; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CH2060
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to return to the manufacturer for investigation; it has not been received.
Event or Problem Description
The exact date of the event is unknown.The event involved a leak of chemotherapy that occurred during patient administration.The customer stated that the chamber was filled up and a lateral spillage occurred involving the plunger and the luer-lock.There was no one harmed as a result of the event.
Additional Manufacturer Narrative
H10: no product samples, videos, or photographs were returned for investigation.The dhr was reviewed and there were no non-conformances found that would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.

• Brand Name: 60ML SYRINGE W/SPINNING SPIROS®, RED CAP
• 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: 9475700
• Report Number: 9617594-2019-00424
• Device Sequence Number: 19498163
• Product Code: ONB
• UDI-Device Identifier: 00840619081232
• UDI-Public: (01)00840619081232(17)210701(10)3304169
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K173477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2019

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 Catalogue Number: CH2060
• Device Lot Number: 3304169
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1