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

Device Problems Fluid/Blood Leak (1250); Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); Chemical Exposure (2570)

Event Date 01/17/2019

Event Type  malfunction  

Manufacturer Narrative

One (1) unused, in an opened pouch, list # ac205, 5 gang 4-way nanoclave stopcock w/baseplate, rotating luer was received for investigation.The open ac205 device was received with three (3) stopcocks on the manifold separated from the base plate.There is presence of solvent bond on all three stopcocks and the base plate.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 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 first of two occurrences.No additional information has been received.

• Brand Name: 5 GANG 4-WAY NANOCLAVE® STOPCOCK W/BASEPLATE, ROTATING LUER
• Type of Device: 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
• Manufacturer Contact: patricia sharpe-gregg, bsn, rn ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 8338845
• MDR Text Key: 137268000
• Report Number: 9617594-2019-00035
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709080010
• UDI-Public: (01)00887709080010(17)221101(10)3572171
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1