MAUDE Adverse Event Report: COVIDIEN DEVON; MARKER, SKIN

Model Number	31146020
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 12/26/17.An investigation is currently under way; upon completion the results will be forwarded.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer states that the team has found our surgical markers to be bleeding and leaving a jagged line for the incision placement.
Additional Manufacturer Narrative
There were no samples received with this complaint therefore an examination of the reported condition could not be made.A review of the device history record (dhr) was not performed during this investigation as the lot number was not received with the complaint.All device history records are reviewed and approved by quality prior to release of product.This product was not being used for treatment or diagnosis.A root cause analysis could not identify a root cause.Since this complaint will be considered as unconfirmed, no corrective or preventive actions will be taken at this time.If additional information or samples are received, the investigation will resume as needed.This complaint will be used for trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: DEVON
• Common Device Name: MARKER, SKIN
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 7158399
• Report Number: 1282497-2018-00011
• Device Sequence Number: 13476846
• Product Code: FZZ
• UDI-Device Identifier: 30884521049813
• UDI-Public: 30884521049813
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: 31146020
• Device Catalogue Number: 31146020
• Device Lot Number: 31146020
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2017
• Supplement Date Received by Manufacturer: 12/03/2017
• Initial Report FDA Received Date: 01/02/2018
• Supplement Report FDA Received Date: 08/16/2018
• Patient Sequence Number: 1