MAUDE Adverse Event Report: Ethicon Inc. BLAKE; Catheter, Irrigation

Catalog Number	2233
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and a drain was used.During the procedure, the drain had adhered to the trocar needle.Another product was used to complete the case.There were no adverse consequences to the patient.Upon evaluation of the device returned, the received displayed evidence of adherence of the drain to the trocar.
Additional Manufacturer Narrative
Product complaint # (b)(4).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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.H3 investigation summary: 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.Retention sample review: no negative observation was found.Review of defective sample's image/video: not applicable, as there was no complaint sample image/video received for evaluation.Complaint sample review: complaint sample received, one complaint sample of drain with trocar was received for evaluation, product was checked visually and found that there was chip-off marks (hole) on upper surface of the drain visible, but no negative observation found on trocar.The sample received displayed evidence of adherence of the drain to the trocar.Although this is not a defect produced by the manufacturing processes, it is considered a defect of the manufactured product.The returned sample was received in an opened condition and was not in the original dmd packaging.As per standard practice, 100% functional test and 100% visual inspection was carried out, before and after packing of finished goods, prior to the product release.There was no scope to miss such defect, at manufacturing/release stage.Hence, it is inconclusive to conclude the complaint as justified at manufacturing end, and lead the complaint to be not-justified.

• Brand Name: BLAKE
• Common Device Name: Catheter, Irrigation
• Manufacturer (Section D): Ethicon Inc.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): Degania India; 251, sector-6, imt manesar; gurugram 12205 2; IN 122052
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; +1(303)552-6892
• MDR Report Key: 50772634
• Report Number: 2210968-2026-09147
• Device Sequence Number: 10528963
• Product Code: GBX
• UDI-Device Identifier: 10705031003613
• UDI-Public: (01)10705031003613(17)290706(10)J2401542
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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: 2233
• Device Lot Number: J2401542
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/13/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2024
• 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