MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY GEM CVP (CALIBRATION VALUATION PRODUCT)1 WITH CO-OX; BLOOD GAS QUALITY CONTROL SOLUTION

Catalog Number	00025000115
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A customer reported that their finger was cut when they snapped open a vial of gem cvp1 with co-ox.The cut was minor; the wound was washed and dressed.An instrumentation laboratory (il) representative contacted the facility.The facility verified that protocol was not followed; the operator should have used the ampoule breaker.Instrumentation laboratory's review of the operator's manual and instruction for use sheet confirmed appropriate instruction for the use of the ampoule breaker to snap open the ampoule.No remedial action is required.
Event or Problem Description
It was reported that a customer cut their finger while snapping open a cvp vial.The customer reported that it was a minor cut.He removed gloves to wash hands with soap and water, then used a bandage.

• Brand Name: GEM CVP (CALIBRATION VALUATION PRODUCT)1 WITH CO-OX
• Common Device Name: BLOOD GAS QUALITY CONTROL SOLUTION
• Manufacturer (Section D): INSTRUMENTATION LABORATORY; 180 hartwell rd; bedford MA 01730
• MDR Report Key: 7415356
• Report Number: 1217183-2018-00003
• Device Sequence Number: 1264859
• Product Code: JJY
• UDI-Device Identifier: 08426950440680
• UDI-Public: 08426950440680
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K112995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/09/2018

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 Catalogue Number: 00025000115
• 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: 03/16/2018
• Initial Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other