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

Catalog Number 00025000115

Device Problem Device Handling Problem (3265)

Patient Problem Needle Stick/Puncture (2462)

Event Date 03/16/2018

Event Type  Injury  

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 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
• Type of Device: BLOOD GAS QUALITY CONTROL SOLUTION
• Manufacturer (Section D): INSTRUMENTATION LABORATORY; 180 hartwell rd; bedford MA 01730
• Manufacturer (Section G): INSTRUMENTATION LABORATORY; 180 hartwell rd; bedford MA 01730
• Manufacturer Contact: shari o'connor ; 180 hartwell rd; bedford, MA 01730 ; 7818614364
• MDR Report Key: 7415356
• MDR Text Key: 105130767
• Report Number: 1217183-2018-00003
• Device Sequence Number: 1
• Product Code: JJY
• UDI-Device Identifier: 08426950440680
• UDI-Public: 08426950440680
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112995
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 00025000115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/16/2018
• Initial Date FDA Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other