MAUDE Adverse Event Report: EPOCAL, INC. CARE-FILL CAPILLARY TUBES; EPOC CAPILLARY TUBES

Catalog Number AT-0006-00-00

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

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

Event Date 09/04/2017

Event Type  malfunction  

Event Description

Phlebotomist went up to nursery to do epoc cap gas on a baby, started epoc and collected my blood went to start running blood on epoc and it said "qc failed".Collected blood 2nd time went to flip tube up to run on epoc and blood was leaking out the bottom of tube before i could run the sample.I called (b)(4) to see if there was any cap.Tubes down by er and if so to bring them up to me.(b)(4) came up with a tray of tubes and i collected blood for the 3rd time ran it and again the blood was leaking out of the bottom of the tube.I called up to processing and talked to (b)(4) to see if there was a tech that could check and see if there was any trays or cap tubes up there with a different lot number.There wasn't so we tried a different tube from another tray.Finally on the 4th try we got one to work.During all this dr.(b)(6) was standing over my shoulder asking "you have to do it again?" i had explained to her what was happening so she could understand.I had the baby's father and also 3 nurses watching all this happen.I called back upstairs and talked to (b)(4) and a tech to see what to do if another epoc cap gas would be ordered.(b)(4) called the "management on call" and ended up coming to the agreement that doing the old cap gasses and running it upstairs would work.The 2nd time i went up to do another cap gas i talked to dr.(b)(6) about collecting the old way and she said "that would work as long as we don't torment the baby again." the phlebotomist who reported this is an experienced lab assistant who had collected capillary epoc specimens many times.

• Brand Name: CARE-FILL CAPILLARY TUBES
• Type of Device: EPOC CAPILLARY TUBES
• Manufacturer (Section D): EPOCAL, INC.; ottawa, on K1G 3 P5; CA K1G 3P5
• MDR Report Key: 6954571
• MDR Text Key: 89624931
• Report Number: MW5072784
• Device Sequence Number: 1
• Product Code: CGL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/02/2017
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2018
• Device Catalogue Number: AT-0006-00-00
• Device Lot Number: 17013-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1