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

Catalog Number	2232
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient underwent an avr and cabe on (b)(6) 2024 and a drain was used.During surgery, the drain was damaged at 20 cm from the drain insertion when milking a sub thoracic drain with alcohol cotton at the ward after the surgery.Drain was replaced.Patient is stable.Further details are not provided, additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned.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 provided: the procedure was aortic valve replacement and coronary artery bypass grafting.After the damage, the product was replaced with a new drain.The patient is stable after the procedure.Additional information has been requested and received.What is the lot number? unk.Please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.The device has been received at sukagawa and will be shipped.Please check rmao.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.Were there any intra-operative complications? if so, what were they? where was the tip of drainage tube located? how was the drain secured? how was the product function verified following the first activation? who monitored the drainage and how often? why was the drain ¿milked¿? was damage noted or issues after milking? please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure the diagnosis and indication for the index surgical procedure? were any concomitant procedures performed? what symptoms did the patient experience following the index surgical procedure? onset date? what date was the 2nd procedure performed replace the new drain? findings, will piece be returned? other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? surgeon¿s name? if applicable, will product be returned? if so, please provide the return date and tracking information.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.
Additional Manufacturer Narrative
Product complaint # (b)(4) additional information has been requested and received.Were there any intra-operative complications? =>no if so, what were they? where was the tip of drainage tube located? =>unk how was the drain secured?=>unk how was the product function verified following the first activation? =>unk who monitored the drainage and how often? =>unk why was the drain ¿milked¿?=>unk was damage noted or issues after milking?=>yes please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure=>unk the diagnosis and indication for the index surgical procedure? =>aortic valve replacement and coronary artery bypass surgery were any concomitant procedures performed?=>see above what symptoms did the patient experience following the index surgical procedure? onset date?=>unk what date was the 2nd procedure performed replace the new drain?=>unk findings, will piece be returned?=>only one pirece will be returned.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?=>no problem surgeon¿s name?=>(b)(6) if applicable, will product be returned? if so, please provide the return date and tracking information.=>the device will be shipped.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: d9.H3 evaluation: complaint sample review : one complaint sample of drain of around 200 mm was received for evaluation, product was inspected visually below were detailed observation: 1.Drain was separated from the tubing area.2.There was a deep dent observed on the perimeter of the drain nearby separation surface.3.A linear cut (till the separation end) was also visible nearby the dent area.Documents review : not applicable, as lot number of the complaint was unknown, hence, batch history review was not performed.Retention sample review : not applicable, as lot number of the complaint was unknown, hence, retention sample review was not performed.Review of defective sample's image / video : not applicable, as there was no complaint sample image / video received for evaluation.It is suspected that, separation surface of the drain might have came in contact with some pinned / sharp tool used prior / during surgery, and lead to the defect generation.External factors like mishandling or improper usage at user end could not be ruled out.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.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 W/ 1/4IN BNDBLE TR
• 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: 20523599
• Report Number: 2210968-2024-11064
• Device Sequence Number: 18421381
• Product Code: GBX
• UDI-Device Identifier: 10705031003606
• UDI-Public: 10705031003606
• 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,Followup,Followup
• Report Date (Section B): 01/02/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 2232
• 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: 09/30/2024
• Supplement Date Received by Manufacturer: 11/14/2024; 12/07/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 12/09/2024; 01/02/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown