MAUDE Adverse Event Report: ETHICON INC. BLAKE 10MM FLAT 3/4; CATHETER, IRRIGATION

Model Number 2217

Device Problem Infusion or Flow Problem (2964)

Patient Problem Failure to Anastomose (1028)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information provided: the sales rep was told that the fact that suction could not be done would not affect the patient.There is no effect on the patient so far.After rectal surgery, leakage occurred from the anastomosis.The surgeon considered that there was no causal relationship with this product for anastomotic leakage.After confirmed the suction failure, the reservoir was removed and milking was performed by manually, and an attempt was made to perform suction forcibly by connecting to the suction air.After that, there is no problem with the patient's condition.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? 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? was another product used? 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.Was an ethicon reservoir used? did it function as intended? product code/lot number? no product is available for return.

Event Description

It was reported a patient underwent an unknown rectal surgery on an unknown date and a drain was used.The drain was placed in the pelvic floor, near the suture site of the rectum.In the ward/icu, anastomotic leakage occurred.It was confirmed by ct that stool was accumulated at the drain tip part.The reservoir was removed and forced to apply pressure, but suction could not be done so ct-guided drainage was performed.There is no effect on the patient so far.Further details are not provided.No sample will be returned.The surgeon considered that there was no causal relationship with this product for anastomotic leakage.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 of event where product had an issue?=>unknown.Were there any intra-operative complications? if so, what were they?=>unknown.Where was the tip of drainage tube located?=>around anastomosis.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.Was another product used?=>unknown.What is the physician¿s opinion as to the etiology of or contributing factors to this event?=>unknown.What is the patient's current status?=>there is no effect on the patient so far.Surgeon¿s name?=>(b)(6).Product lot number?=>unknown.If applicable, will product be returned? if so, please provide the return date and tracking information.=>no sample will be returned.Was an ethicon reservoir used?=>unknown.Did it function as intended?=>unknown.Product code/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 10MM FLAT 3/4
• 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: 14270230
• MDR Text Key: 291394340
• Report Number: 2210968-2022-03210
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003538
• UDI-Public: 10705031003538
• 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: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2217
• Device Catalogue Number: 2217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/13/2022
• 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