MAUDE Adverse Event Report: ETHICON INC. BLAKE SI DRAIN HBLS 19FR RND W/ 1/4IN BN; CATHETER, IRRIGATION

Catalog Number	2232
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned.Additional information provided: 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.Please confirm the date of cabg procedure (b)(6)2025? = yes please confirm the date of event where product had an issue 14-feb-2025? = yes.Were there any intra-operative complications? if so, what were they? = unk where was the tip of drainage tube located? = unk how was the drain secured? = unk what was the date of first activation? = unk how was the product function verified following the first activation? =>unk who monitored the drainage and how often? = unk where was leakage noted? = unk please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedurethe diagnosis and indication for the index surgical procedure? =>unk were any concomitant procedures performed? =>unk what symptoms did the patient experience following the index surgical procedure? onset date? =>unk was a 2nd procedure performed replace a new drain? =>unk if yes-date of 2nd procedure? other relevant patient history/concomitant medications? =>unk what is the physician¿s opinion as to the etiology of or contributing factors to this event? =>unk what is the patient's current status? =>unk surgeon¿s name? =>mitsuhiro yano if applicable, will product be returned? if so, please provide the return date and tracking information.=>we regularly contact with sale rep about the device returning.H3 evaluation: no product returned.Complaint sample review: not applicable, as per the complaint details 'no sample will be returned', and we are well aware with the fact that to perform a complete holistic investigation, defective samples are required, so scope of the investigation is very limited at our end.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.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.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 an open coronary artery bypass grafting surgery on an (b)(6) 2025 and a drain was used.In wards/icu, it was found that there was a crack on the middle of the drain, and a leak occurred.A replacement drain was put out, so the patient had no problems at all.The product was used on the chest.It is thought something happened during the procedure in the hospital that caused the damage.No sample will be returned.There were no adverse consequences to the patient.Further details are not provided.No product returning.Additional information has been requested.

• Brand Name: BLAKE SI DRAIN HBLS 19FR RND W/ 1/4IN BN
• 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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21630252
• Report Number: 2210968-2025-02835
• Device Sequence Number: 15520261
• Product Code: GBX
• UDI-Device Identifier: 10705031003606
• UDI-Public: (01)10705031003606(11)240417(17)290417(10)J2400787
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 2232
• Device Lot Number: J2400787
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown