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

Model Number 2232

Device Problem Leak/Splash (1354)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/17/2022

Event Type  Injury  

Event Description

It was reported a patient underwent an aortic valve replacement on (b)(6) 2022 and a drain was used.After the surgery, in the icu, the surgeon confirmed that air leakage occurred at the connection part.The connection between the connector and the drain was held together by something like a zip tie.A drain was found broken in the area in contact with the tip of the connector.The doctor commented that a metal part of a milking roller was the cause of the breakage.There were no adverse consequences to the patient.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Additional information: the product was placed into intracardiac and anterior mediastinum and connected to a low-pressure continuous suction equipment.At that time, a y-type connector was connected.After the surgery, when an experiment was performed to flow water using the product, water flowed out from the drain rupture part.After the leakage occurred, the product was replaced by the doctor.It was reported that no health hazard occurred to the patient.The doctor commented that a metal part of a milking roller was the cause of the breakage.Additional information has been requested and received.What is the lot number for each of the involved products? no further information is available.Please clarify the number of products involved in the event and how many to be returned? qty of product involved and to be returned of bcc2 is 1.Qty of product involved and to be returned of 2232 is 2.Device return status: we regularly contact with sales rep about the device returning.No further information will be provided.Additional information has been requested and received.Attempts have been made to obtain the device, not received to date.If further details are received at a later date a supplemental medwatch will be sent.Response received stating "product was replaced by the doctor" was surgical intervention performed to place 2 new drains? please provide details and dates.Events reported on mw# 2210968-2022-04473, mw# 2210968-2022-04475.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.

Manufacturer Narrative

Product complaint # (b)(4).Additional information has been requested and received.Attempts have been made to obtain the device, however not received to date.If further details are received at a later date a supplemental medwatch will be sent.Response received stating product was replaced by the doctor was surgical intervention performed to place 2 new drains? no further information is available.Please provide details and dates.Event date was (b)(6) 2022.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.

Manufacturer Narrative

Product complaint # (b)(4).The product was returned for evaluation.One used sample connector received for evaluation both ports of connector were clamped with piece of drain at each side with the help of a zip ties.Size of the drains attached on connector is drain a) 30 mm (incomplete: cut or broken) and drain b) 45 mm (incomplete: cut or broken).The side from which leakage occurred was not clearly defined in the complaint statement.Hole was observed in the drain (drain size 45 mm) at the edge of connection part which is likely to happen due to twisting of drain during the surgery.No manufacturing defect was observed.Improper handling and improper usage at user end could not be ruled out.Further investigation of the sample was not possible.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.

Manufacturer Narrative

Product complaint # (b)(4).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.Date of index surgical procedure?=> (b)(6) 2022 was the date the drain observed as broken (b)(6) 2022?=>yes was a 2nd procedure performed to place 2 new drains via surgical intervention?=>no further information is available.If yes, what was the date of drain replacement procedure? who monitored the drainage and how often?=>no further information is available.What symptoms did the patient experience following the index surgical procedure? onset date?=>no further information is available.Other relevant patient history/concomitant medications?=>no further information is available.What is the physician¿s opinion as to the etiology of or contributing factors to this event?=>the surgeon said that the breaking had been caused by a milking roller.What is the patient's current status?=>no further information is available.Product lot number?=>no further information is available.Will product be returned, please provide the return date and tracking information?=>the device was shipped no further information will be provided." 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
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): DEGANIA INDIA; 251, sector-6, imt manesar; gurugram ; IN
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14656274
• MDR Text Key: 301649031
• Report Number: 2210968-2022-04474
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003606
• UDI-Public: 10705031003606
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: CL I EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/17/2022

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
• Device Operator: Health Professional
• Device Model Number: 2232
• Device Catalogue Number: 2232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/24/2022
• Initial Date FDA Received: 06/10/2022
• Supplement Dates Manufacturer Received: 06/14/2022; 07/06/2022; 08/10/2022
• Supplement Dates FDA Received: 07/06/2022; 07/26/2022; 08/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male