MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14 CM (5.5") SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS, ROTATING; STOPCOCK, I.V. SET

Catalog Number 011-MC33126

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hyperglycemia (1905)

Event Date 10/15/2019

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned but has not yet been received.

Event Description

It was reported that the device, involved in the event, experienced a leak on one of the valves causing a return on the second path into the medication bag with insulin.The event occurred during patient use and resulted in high hyperglycemia in a premature baby.The device was replaced without further incident.There was no additional patient harm reported.No additional information is available at this time.

Manufacturer Narrative

The used 011-mc33126 bi-fuse extension set was returned with silicone seal damage.Leak testing showed the seal damage to be the source of the leakage.The seal damage is typical of access with an incompatible mating device.The probable cause of the silicone seal damage that resulted in leakage is access with an incompatible mating device during use.No mating devices were returned to evaluate with the used 011-mc33126 bi-fuse extension set.No device history review (dhr) was conducted since no lot number was identified.

• Brand Name: 14 CM (5.5") SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS, ROTATING
• 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; colonia rancho santa clara, ma; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 9302816
• MDR Text Key: 219216062
• Report Number: 9617594-2019-00383
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-MC33126
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Date Manufacturer Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1