MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5 GANG 4-WAY NANOCLAVE® STOPCOCK W/BASEPLATE, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	AC205
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Chemical Exposure (2570)
Date of Event	01/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One (1) new, list # ac205, 5 gang 4-way nanoclave stopcock w/baseplate, rotating luer was received for investigation.The packaged ac205 device was received with four (4) stopcocks on the manifold separated from the base plate.There is presence of solvent bond on all four stopcocks and the base plate.The package has small indentations on the clear side of the package like the manifold was manipulated in the package.The reported product problem for leakage and nanoclaves separated from the stopcocks on the manifold was not confirmed on the returned sample.However the stopcocks were found separated from the base plates.It is not known if intentional force was used to on the stopcock/base plate bonds since there is solvent bonding present.The lot # 3572171 and relevant commodities were reviewed and there were no relevant non-conformances found.
Event or Problem Description
The event involved a 5 gang 4-way nanoclave stopcock w/baseplate, rotating luer where there was reported integrated clave failures on the 5 port manifolds, which resulted in a significant spill of cisplatin.There was patient involvement, however there was no report of harm.This report captures the second of two occurrences.No additional information has been received.

• Brand Name: 5 GANG 4-WAY NANOCLAVE® STOPCOCK W/BASEPLATE, ROTATING LUER
• 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: 8338848
• Report Number: 9617594-2019-00036
• Device Sequence Number: 11251298
• Product Code: FMG
• UDI-Device Identifier: 00887709080010
• UDI-Public: (01)00887709080010(17)221101(10)3572171
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K080077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 01/24/2019

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: 11/01/2022
• Device Catalogue Number: AC205
• Device Lot Number: 3572171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 02/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1