MAUDE Adverse Event Report: COVIDIEN DEVON; MARKER, SKIN

Model Number	31145777
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 09/18/2017.An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reports that the open marker cap and the tip of the pen was damaged.There was no patient involvement.
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 sample to evaluate.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.A production notification was issued to all personnel to ensure that they are aware on the condition reported by the customer.The current process is running according to product specifications meeting quality acceptance criteria.If additional information is received warranting further analysis, the investigation will be resumed.This complaint will be used for tracking and 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; calle 9 sur no. 1113 cuidad; tijuana 22444 ; MX 22444
• MDR Report Key: 6874836
• Report Number: 9612030-2017-05174
• Device Sequence Number: 18953508
• Product Code: FZZ
• UDI-Device Identifier: 20884527007506
• UDI-Public: 20884527007506
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2018

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: Other
• Device Expiration Date: 04/01/2020
• Device Model Number: 31145777
• Device Catalogue Number: 31145777
• Device Lot Number: 7100106564
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/22/2017
• Supplement Date Received by Manufacturer: 08/22/2017
• Initial Report FDA Received Date: 09/18/2017
• Supplement Report FDA Received Date: 02/13/2018
• Patient Sequence Number: 1