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

Model Number 2229

Device Problem Infusion or Flow Problem (2964)

Patient Problems Hematoma (1884); Insufficient Information (4580)

Event Date 05/01/2022

Event Type  Injury  

Event Description

It was reported a patient underwent a mastectomy on an unknown date and a drain was used.In the icu, drainage could not be performed from the day of start of use until midnight.When the fixing suture was cut, suction began to be applied.On the following day, thoracotomy was performed, and it was found that hematoma developed, which was treated.[treatment details] the surgeon opened the wound again the day after surgery and the hematoma was treated.The patient was anesthetized.There was no prolongation of hospitalization.The surgeon¿s opined: that the flow rate of the drain maybe became as close to zero as possible because the fixing suture was tied with strong force.Saline did flow when it was passed through before the fixation suture was removed.If it becomes a little thick like blood, maybe it may not pass.Further details are not provided.No sample will be returned.Additional information has been requested.

Manufacturer Narrative

(b)(4).Additional information: current status of the patient: she was discharged from the hospital.Progress: the first medical examination after discharge was completed, and necrosis of the skin did not occur, but during the recovery process, it was confirmed that the skin seemed to have a yellowish color.Treatment plan: none.Seriousness: non-serious (moderate/minimal).Reason of the seriousness: the patient was discharged from the hospital as scheduled, and no skin necrosis occurred.Product use details: a drain was placed before the wound was closed.At the time, it was fixed with 2-0 silk.Suction could not be confirmed from right after a mastectomy until midnight on that day.After cutting the fixation suture, suction was started to be applied.Additional information has been requested however not received.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? what was the date of first activation? who monitored the drainage and how often? was intervention performed to place a new drain? what treatment /intervention was performed to address hematoma? please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure date and name of index surgical 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? 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? lot number? no product is available for return.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.If further details are received at a later date a supplemental medwatch will be sent.Date of procedure? unknown, but about 3 weeks ago from june 13.Date of event where product had an issue? the same date with the procedure.Dr said from right after the procedure to midnight of the day were there any intra-operative complications? if so, what were they?=>not reported.What was the date of first activation? the same date with the procedure.Who monitored the drainage and how often?=>unknown.Was intervention performed to place a new drain? reoperation was performed to address hematoma.What treatment /intervention was performed to address hematoma? reoperation was performed to address hematoma.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure=>gender is female.Date and name of index surgical procedure?=>mastectomy.The diagnosis and indication for the index surgical procedure? =>unknown.Were any concomitant procedures performed?=>unknown.What symptoms did the patient experience following the index surgical procedure? onset date?=>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? it is probable that the flow rate of the drain decreased due to the strong tying of the fixed suture.Before removing the fixation suture, it flowed when passed through saline.Doctors think that viscous liquids like blood may not pass through the drain.What is the patient's current status? the patient was discharged from the hospital as scheduled, and no skin necrosis occurred.Lot number?=>unknown.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 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: 14840307
• MDR Text Key: 295114434
• Report Number: 2210968-2022-04889
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003576
• UDI-Public: 10705031003576
• 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
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2229
• Device Catalogue Number: 2229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Sex: Female