MAUDE Adverse Event Report: BIO-RAD LABORATORIES, INC LIQUICHEK BLOOD GAS EGL CONTROL; CONTROLS FOR BLOOD-GASES (ASSAYED AND UNASSAYED)

Catalog Number	511
Medical Device Problem Code	Human Factors Issue (2948)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	02/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Liquichek blood gas plus egl control is not manufactured from a biological source material.This product is a buffered bicarbonate and electrolyte solution and contains no constituents of human or animal material.
Event or Problem Description
The coordinating analyst contacted bio-rad to report a finger cut involving liquichek blood gas plus egl control, lot 29510.The lab technician cut a finger when breaking an ampule to open it prior to running on an analyzer.The technician received care by the hospital's emergency team.The incident occurred in the hospital laboratory.The technician wa not wearing gloves or using an ampule breaker.

• Brand Name: LIQUICHEK BLOOD GAS EGL CONTROL
• Common Device Name: CONTROLS FOR BLOOD-GASES (ASSAYED AND UNASSAYED)
• Manufacturer (Section D): BIO-RAD LABORATORIES, INC; 9500 jeronimo rd; irvine CA 92618 2017
• MDR Report Key: 7355467
• Report Number: 2016706-2018-00002
• Device Sequence Number: 16500539
• Product Code: JJS
• UDI-Device Identifier: 00847661003540
• UDI-Public: 00847661003540
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K002535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other Health Care Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 511
• Device Lot Number: 29510
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2018
• Initial Report FDA Received Date: 03/20/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other