MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SPIROS CLOSED MALE LUER; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	20120-01
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	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation.
Event or Problem Description
A medsun/medwatch voluntary report ((b)(4)) was received, which stated the following "when the spiros valve was placed on the chemo infusion unit, it was found to be leaking fluid , on examination it was noted to be cracked." the event occurred in (b)(6) 2019 on an unknown date.There was patient involvement, however no report of adverse event or delay in therapy.

• Brand Name: SPIROS CLOSED MALE LUER
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 8893383
• Report Number: 9617594-2019-00265
• Device Sequence Number: 1413174
• Product Code: FPA
• UDI-Device Identifier: 00840619023294
• UDI-Public: (01)00840619023294(17)231001(10)94-243-SJ
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K070532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2023
• Device Catalogue Number: 20120-01
• Device Lot Number: 94-243-SJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 YR