MAUDE Adverse Event Report: ICU MEDICAL INC 4-WAY HIGH FLOW STOPCOCK W/ROTATING LUER; STOPCOCK, IV SET

Catalog Number SC100

Device Problems Break (1069); Detachment Of Device Component (1104); Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2017

Event Type  malfunction  

Event Description

Patient on ecmo.Stop cock on white lumen of r ij shattered and fell apart after eeg lead removal with collodian remover.Event occurred twice (two different patients).Per (b)(6): spoke with the lead eeg tech on today the collodion remover used is known to have a corrosive effect on simple plastics.The patient in the cicu had an ij and it could very well be that this oil based product came in contact with the stop cock.The nurses are usually instructed to shampoo the pts hair to remove any of the residue product.Will speak with eeg today to see if there could be a practice change for those patients having an eeg with ivs in close proximity to the head.Have attached the manufacturer's data sheet on this.Have sent out a communication to the techs to be aware that this can happen.The other alternative for this product is an acetone base remover which the techs do not use in the cicu since it interacts poorly with the vad pumps.Supervisor cicu looking to see if there is a product alternative.Note on colloidal remover package insert: use with care: may discolor or remove furniture paints.May melt low density plastics.May dissolve exam gloves.For external use only! may cause eye irritation.Do not use on open wounds! keep container tightly closed.Discontinue if skin irritation occurs.

• Brand Name: 4-WAY HIGH FLOW STOPCOCK W/ROTATING LUER
• Type of Device: STOPCOCK, IV SET
• Manufacturer (Section D): ICU MEDICAL INC; 4455 atherton dr.; salt lake city UT 84123
• MDR Report Key: 6263381
• MDR Text Key: 65257722
• Report Number: 6263381
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: SC100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/17/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 3