MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. EXT SET TUBING PUR AMBRATE, SPIKE, Y-CLAVE, LUER CHECK VALVE; STOPCOCK, I.V. SET

Catalog Number 011-H1225

Device Problem Fluid/Blood Leak (1250)

Patient Problems Headache (1880); Nausea (1970); Malaise (2359); Chemical Exposure (2570)

Event Date 10/05/2018

Event Type  malfunction  

Manufacturer Narrative

The device was discarded.Additionally, no sister samples are available for investigation.The reported complaint cannot be confirmed without a returned sample.A dhr (device history review) lot review was conducted because no lot number(s) was/were identified.

Event Description

The event involves an extension set with an unknown lot number that had a rupture proximal to the y connection near the end of the yellow line causing a leak of busulfan.The pharmacy assistant had direct dermal contact with the medication and later presented with nausea, migraine, and general malaise requiring medical assistance and has since recovered.No other information has been provided.

• Brand Name: EXT SET TUBING PUR AMBRATE, SPIKE, Y-CLAVE, LUER CHECK VALVE
• 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: 8248936
• MDR Text Key: 134364392
• Report Number: 9617594-2019-00011
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-H1225
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR
• Patient Weight: 50