MAUDE Adverse Event Report: ETHICON A JOHNSON AND JOHNSON CO BLAKE SILICONE DRAIN

Model Number	2230.P05/LAB0012033.4
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/14/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
While being removed by the surgeon, the drain tore and it was estimated about 4-6cm portion was retained in the chest.

• Brand Name: BLAKE SILICONE DRAIN
• Common Device Name: BLAKE SILICONE DRAIN
• Manufacturer (Section D): ETHICON A JOHNSON AND JOHNSON CO; somerville NJ 08876
• MDR Report Key: 6839185
• Report Number: MW5071920
• Device Sequence Number: 10940561
• Product Code: GBX
• UDI-Device Identifier: 10705031003583
• UDI-Public: (01)10705031003583
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/30/2017

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: No Information
• Device Expiration Date: 10/31/2021
• Device Model Number: 2230.P05/LAB0012033.4
• Device Catalogue Number: 2230
• Device Lot Number: J1613394
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/01/2017
• 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: Required Intervention
• Patient Age: 65 YR