MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 9.5" EXT SET W/CLAVE, GRADUATED CONNECTOR, CLAMP; STOPCOCK, I.V. SET

Catalog Number	CH3196
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Chemical Exposure (2570)
Date of Event	06/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product samples, videos, or photographs were returned for investigation.The device history review (dhr) for lot 3302560 was reviewed and there were no relevant 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.
Event or Problem Description
A medsun mandatory and voluntary event report (mw5095033) was received, which stated the following "the graduated connector 9.5 in., 3.2ml extension set reference# ch3196, lot number 3302560 with an expiration date of aug-2021 used to instilled chemotherapy into bladder, the device leaked and chemotherapy spilled onto patient.Fda safety report id#(b)(4)." there was patient involvement, however, no report of adverse event and no human harm.

• Brand Name: 9.5" EXT SET W/CLAVE, GRADUATED CONNECTOR, CLAMP
• Common Device Name: STOPCOCK, I.V. SET
• 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: 10346117
• Report Number: 9617594-2020-00277
• Device Sequence Number: 19038713
• Product Code: FMG
• UDI-Device Identifier: 00840619025410
• UDI-Public: (01)00840619025410(17)210801(10)3302560
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 07/07/2020

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: 08/01/2021
• Device Catalogue Number: CH3196
• Device Lot Number: 3302560
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1