MAUDE Adverse Event Report: ETHICON INC. BLAKE; CATHETER, IRRIGATION

Catalog Number	2233
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # = (b)(4) additional information provided: -lot number of (b)(4) : unk j2500784 the same situation has occurred three times in a row.Additional information has been requested however not received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.Did the drain come in contact with surgical instruments, surgical needles, sutures, sharp objects at any time? how was the case completed? it was indicated that the same situation has occurred three times in a row.Could you please confirm how many devices demonstrated the alleged deficiency? could you kindly perform and document the follow-up attempt for the product return? please provide the source or name of person providing answers to follow-up questions: 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.
Event or Problem Description
It was reported a patient underwent a spinal surgery on an unknown date and a drain was used.The drain was inserted before wound closure and the procedure appeared to have been performed correctly, but there was a sound like an air leak and the reservoir could not suck exudate when connected to the bag and starting to draw fluid.The doctor said that this has never happened before.There were no adverse consequences to the patient.Further details are not provided.Additional information has been requested.

• 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 ; 3035526892
• MDR Report Key: 25028261
• Report Number: 2210968-2026-04631
• Device Sequence Number: 21126022
• Product Code: GBX
• UDI-Device Identifier: 10705031003613
• UDI-Public: (01)10705031003613(17)300607(10)J2500784
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/16/2026

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: J2500784
• 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: 04/10/2026
• Supplement Date Received by Manufacturer: 05/07/2026; 06/05/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 05/28/2026; 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown