MAUDE Adverse Event Report: ETHICON INC. BLAKE SI DRAIN 10MM FLAT 3/4 FLUTED W/ 3/16IN TR; CATHETER, IRRIGATION

Catalog Number	2217
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a patient underwent an unknown procedure on an unknown date in (b)(6) 2024 and a drain was used.The surgeon wanted to put this drainage device (drainage tunneling) from the abdomen to the skin and the drain broke between the flat silicone drain and the suction tubing.No consequences for the patient.Use of another drain from a different lot.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned additional information provided: but risk of injury for the surgeon.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.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.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4) additional information: d9 h3 evaluation: one complaint sample of drain, with separated white flat portion was received for evaluation, product was inspected visually, below were detailed observations: 1.Flat portion of drain was separated from the hub area.2.Separation surface of the hub was inspected at 10x zoom level, and found that there were deep cut marks present on the hub edges.3.Also, the similar marks were presented on the separation surface of flat portion.Retention sample review : no negative observation was found.Documents review : during investigation of complaint, batch review of in-process and final packaging inspections, as well as the manufacturing process is performed, these products are reported to be manufactured, inspected, and packaged in conformance with customer's specifications and have been found to be acceptable within all parameters.No discrepancy as per the reported defect is observed.It is suspected that, cut-off end of the drain might have came in contact with some pinned / sharp tool used prior / during surgery, and lead to the defect generation.External factors like mishandling or improper usage at user end could not be ruled out.As per standard practice, 100 % functional test and 100% visual inspection was carried out visually before and after packing of finished goods, prior to the product release.There is no scope to miss such defect, at manufacturing / release stage.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.

• Brand Name: BLAKE SI DRAIN 10MM FLAT 3/4 FLUTED W/ 3/16IN TR
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.; 1000 route 202; raritan 08869 0151
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18818014
• Report Number: 2210968-2024-02202
• Device Sequence Number: 4342412
• Product Code: GBX
• UDI-Device Identifier: 10705031003538
• UDI-Public: 10705031003538
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2024

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 Catalogue Number: 2217
• Device Lot Number: J2304435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2024
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown