MAUDE Adverse Event Report: COVIDIEN DEVON; MARKER, SKIN

Model Number	31145827
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: 12/26/2017.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 submitted with this complaint.The complaint shall be reopened if a sample is received.The reported condition by the customer could not be confirmed without a physical sample or photograph to analyze.The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the condition described by the customer.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.The root cause for the reported condition cannot be specifically identified without a representative sample; therefore, corrective action will be limited to the manufacturing awareness this time.The current process is running according to product specifications meeting quality acceptance criteria.We will keep monitoring the process for any adverse trends that require immediate attention.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; calle 9 sur no. 1113 cuidad; tijuana,na 22444 ; MX 22444
• MDR Report Key: 7145617
• Report Number: 9612030-2017-05260
• Device Sequence Number: 1108986
• Product Code: FZZ
• UDI-Device Identifier: 10884527016006
• UDI-Public: 10884527016006
• 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,litera
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2018

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: 05/31/2020
• Device Model Number: 31145827
• Device Catalogue Number: 31145827
• Device Lot Number: 1715777464
• 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: 12/26/2017
• Supplement Report FDA Received Date: 03/21/2018
• Patient Sequence Number: 1