MAUDE Adverse Event Report: ETHICON INC. BLAKE SI DRAIN HBLS 19FR RND; CATHETER, IRRIGATION

Catalog Number	2230
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and a drain was used.At the wards/icu, it was found that the device was broken outside of the body part.How it was managed afterward, the product name, and whether there was any impact on the patient are still being confirmed.Another product was used to complete the case.There were no adverse patient consequences.No sample will be returned.Additional information was requested.
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.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.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? was the broken drain removed completely from the patient? were any pieces left inside the patient? if yes, was the patient taken back to the operating room to remove the broken drain surgically? if not already removed, are there any plans in place to remove the drain from the patient? did the reported issue contribute to any patient adverse consequences? what is the current condition of the patient? could you please provide the lot number? please provide the source or name of person providing answers to follow-up questions:.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information provided: due to the breakage of the product, there were no injuries to the patient or medical staff.Gauze had been wrapped around the tube, and leakage was noticed because the gauze became dirty.After the drain broke, since the drainage volume had decreased 5th day after surgery, it was repaired with polyurethane tape.There has been no impact on the patient¿s condition, and the patient was discharged as scheduled.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? ¿unk.* was the broken drain removed completely from the patient? ¿no; the drain was not removed and was repaired externally with polyurethane tape.* were any pieces left inside the patient? ¿no; the break occurred in the external portion of the drain, and no fragments remained inside the patient.* if yes, was the patient taken back to the operating room to remove the broken drain surgically? ¿not applicable.* if not already removed, are there any plans in place to remove the drain from the patient? ¿no; the drain was repaired, and the patient was subsequently discharged as planned.* did the reported issue contribute to any patient adverse consequences? ¿no; there was no injury to the patient or healthcare professionals, and no clinical impact on the patient was reported.* what is the current condition of the patient? ¿the patient had no impact on clinical condition and was discharged according to the planned schedule.* could you please provide the lot number? => unk.* please provide the source or name of person providing answers to follow-up questions:=>(b)(4).H3 evaluation: a photo received for analysis is completed.Received picture were visually examined, and the following observations were made: photo1: the fluted portion of the drain is visible in the shared image, with significant blood staining observed.A red-circled area is marked on one side of the drain; however, with reference to the complaint detail- no visible crack is observed in the image.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 19FR RND
• 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: 24203513
• Report Number: 2210968-2026-01036
• Device Sequence Number: 12152027
• Product Code: GBX
• UDI-Device Identifier: 10705031003583
• UDI-Public: 10705031003583
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2026

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: 2230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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