MAUDE Adverse Event Report: ETHICON INC. BLAKE SI DRAIN HBLS 15FR RND W/ 3/16IN BNDBLE TR; CATHETER, IRRIGATION

Model Number 2233

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).The patient is doing well after re-operation.[treatment details] drainage from the drain of the patient who underwent surgery for neck lymphadenectomy could not be performed well, so re-operation was performed.-on the next day of the first surgery, the patient became able to move in the ward, and it was noticed that the drain did not work properly.At first, the surgeon did not notice that the drain was damaged, and thought that it was caused by placement in the pharynx, and the re-operation was performed.At that time, damage of the drain was found.It was unknown when it was cracked.[surgeon¿s comment] although re-operation was performed due to the drain damage, the patient is getting better and there is no problem.[other contributing factor] the surgeon thought that the method of placement in the pharynx was poor, but the sales rep confirmed that there was no problem with the method.Re-operation was performed due to the drain breakage which was happened in the ward/icu.[product use details] re-operation was performed due to the drain breakage which was happened in the ward/icu.One of the two drains had a crack about 8 cm above the end of the slide.[current status of the patient] the patient is in the hospital.[progress] unk [health injury details] re-operation was performed.[treatment details] it's currently being confirmed.[surgeon¿s opinion about causal relationship between product and event] yes, there is.[surgeon¿s comment and other contributing factor] it's currently being confirmed.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.Date of procedure? date of event where product had an issue? were there any intra-operative complications? if so, what were they? where was the tip of drainage tube located? how was the drain secured? what was the date of first activation? how was the product function verified following the first activation? who monitored the drainage and how often? when was the malfunction first noted? was leakage detected? if so, where? 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? 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? product lot number? 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.

Event Description

It was reported a patient underwent an unknown otolaryngology/head and neck surgery on an unknown date and a drain was used.A drain breakage which happened in the ward/icu.Drainage could not be performed well.Re-operation was performed on (b)(6) 2022 due to the drain breakage which had a crack about 8 cm above the end.Further details are not provided.The patient is doing well after re-operation.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Additional information has been requested and received.If further details are received at a later date a supplemental medwatch will be sent.Date of procedure?=>unknown date, reoperation was on 29th aug.Date of event where product had an issue?=>unknown.Were there any intra-operative complications? if so, what were they?=>not reported.Where was the tip of drainage tube located?=>unknown.How was the drain secured?=>unknown.What was the date of first activation?=>unknown.How was the product function verified following the first activation?=>unknown who monitored the drainage and how often?=>unknown.When was the malfunction first noted?=>on the next day of the first surgery, the patient became able to move in the ward, and it was noticed that the drain did not work properly.Was leakage detected? if so, where?=>unknown please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure=>unknown.The diagnosis and indication for the index surgical procedure?=>unknown.Were any concomitant procedures performed?=>unknown other relevant patient history/concomitant medications?=>unknown what is the physician¿s opinion as to the etiology of or contributing factors to this event?=>he confirmed that the way drain was placed was no problem.What is the patient's current status?=>the patient is getting better.Surgeon¿s name? yuji hirata product code and lot number?=>2233/ lot number is unk if applicable, will product be returned? if so, please provide the return date and tracking information.=>we've already shipped the device.H3 evaluation: one used sample of drain received without trocar.A cut found on the hose area of drain.100% inspection carried out before packing of finished goods and after packing again 100% inspection performed for finished goods at manufacturer before release.The cutting mark might likely to happen with some sharp tool used during the surgery.External factors like improper handling and improper usage at user end could not be ruled out.Therefore further investigation of the sample was not possible.The device/photo upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.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).H3 evaluation: analysis of customer provided photographs, quantity 6, were checked visually, and concluded that.Picture-1 : tiny mark is visible on the drain.Picture-2 : no visible observation.Picture-3 : some red marks are visible over the drain.Picture-4 : on enlarged picture, cut mark is visible.Picture-5 : on enlarged picture, cut mark is visible.Picture-6 : on enlarged picture, cut mark is visible.Furthermore, the point of concern was not to nullify the statement that cut was observed or not rather noted drain was having a cut.Now the investigation moves around the probable root causes to cross verify if such kind of problems can be generated at manufacturer or not.It is very evident that the cause of the cut will be if drain meets some sharp edge tool.During investigation it was observed that no such tool was used at any stage throughout the manufacturing process.Further to add, there were no such incidences of cut drain reported during the in process checks and controls.To elaborate more on controls.The drains are checked 100% before release, so there is no chance of spillage of such defective pieces from manufacturing end.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 15FR RND W/ 3/16IN 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 ; 9083863534
• MDR Report Key: 15472948
• MDR Text Key: 300563159
• Report Number: 2210968-2022-07817
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003613
• UDI-Public: 10705031003613
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2233
• Device Catalogue Number: 2233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention