MAUDE Adverse Event Report: ETHICON INC. BLAKE SI DRAIN HBLS 10FR RND W/ 1/8IN; CATHETER, IRRIGATION

Catalog Number	2227
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a patient underwent an unknown surgery on an unknown date a drain was used.The drain had adhered to the bag with strong adhesive but it was forcibly removed and used.It was found that air had accumulated in the bag and caused a leak after starting use.The leaking area is between the inside and outside of the patient's body cavity.Currently, the leaking area has been taped up, and there have been no health problems for patient.No sample will be returned.Further details are not provided.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.Additional information has been requested and 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? ¿ it is unknown.There is no information indicating contact with surgical instruments, needles, sutures, or other sharp objects; however, the drain was strongly adhered to the bag with adhesive and was forcibly separated before use.Were there any unexpected outcomes or complications resulting from the leak? ¿ no unexpected outcomes or complications were reported, and no patient health damage was observed.What is the current status of the patient? ¿ the patient has no reported health issues and remains stable.Could you please provide the lot number? ¿ unk.Please provide the source or name of person providing answers to follow-up questions: ¿(b)(4).No product is available for return.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 HBLS 10FR RND W/ 1/8IN
• 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: 24652085
• Report Number: 2210968-2026-02914
• Device Sequence Number: 9876509
• Product Code: GBX
• UDI-Device Identifier: 10705031003552
• UDI-Public: 10705031003552
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/20/2026

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: 2227
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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