MAUDE Adverse Event Report: ETHICON INC. BLAKE 7MM FLAT FULL; CATHETER, IRRIGATION

Model Number	2211
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).
Event or Problem Description
It was reported a patient underwent an initial diagnosis for malignant breast tumor on (b)(6) 2020, and a drain was used.When placed, it unraveled.Attempted to attach, but it would not create vacuum.No patient consequences reported.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 4/19/2021.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate product complaint # (b)(4).Date sent to the fda: 4/19/2021.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 5/12/2021.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: BLAKE 7MM FLAT FULL
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 11010659
• Report Number: 2210968-2020-09923
• Device Sequence Number: 19049766
• Product Code: GBX
• UDI-Device Identifier: 10705031003477
• UDI-Public: 10705031003477
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: CL I EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/26/2020

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: 06/20/2024
• Device Model Number: 2211
• Device Catalogue Number: 2211
• Device Lot Number: J1914843
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/26/2020
• Supplement Date Received by Manufacturer: 03/24/2021; 04/28/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 04/19/2021; 05/12/2021
• Patient Sequence Number: 1
• Patient Age: 33 YR