MAUDE Adverse Event Report: ETHICON INC. BLAKE SI DRAIN 7MM FLAT FULL FLUTED W/ 3/16IN TR; CATHETER, IRRIGATION

Model Number 2212

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned.Additional information has been requested and received.Attempts to obtain the product sample have been made.If further details are received at a later date a supplemental medwatch will be sent.What is the lot number? what i had sent in are the faulty products.1 blake drain 2212, lot j2147339.1 blake drain 2212, lot j2137894.1 unknown blake drain, unknown lot number.Was the drain used in the patient? was leakage detected? was the connection issue noticed before activating the reservoir? did the reservoir function properly upon first activation? if yes, how long after the first activation happened did the issue occurred? please verify if the connection was loose between the adapter and reservoir, or the drain and the adapter? was the new drain used to correct the situation placed during a second procedure? did this issue contribute to any patient adverse event? please provide the source or name of person providing answers to follow-up questions (not the person relaying/submitting answers to loc or chu).Is the device available to be returned for evaluation? note: events reported on: mw# 2210968-2023-03408, mw# 2210968-2023-03410.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 procedure on an unknown date and drain was used.The connection point between the drain and the tubing kept disconnecting and another like device was used to complete the procedure.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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: complaint samples of drain were received for evaluation, during visual inspection it was found that flat part of one drain was separated, and there were minor cracks nearby hub area of other two drains.Also, fine fluid trace were there inside the drains, which clarifying that the drains were in use, and were not damaged while pouch was opened.It is suspected that, trocar might have came in contact with some sharp tool or object used during the surgery, and lead to the defect generation.External factors like mishandling or improper usage at user end could not be ruled out.Therefore, further investigation of the received samples is not possible, as these factors are out of scope.Furthermore, no non-compliances was observed in favour or the complaint statement.As per standard practice, 100% inspection was carried out, visual.Before and after packing of finished goods, prior to the product release.There was no scope at manufacturers end to miss such defect, at manufacturing / release stage.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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 7MM FLAT FULL FLUTED 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 ; 9083863534
• MDR Report Key: 16892191
• MDR Text Key: 314839391
• Report Number: 2210968-2023-03409
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003484
• UDI-Public: 10705031003484
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CL I EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2212
• Device Catalogue Number: 2212
• Device Lot Number: J2137894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/12/2023
• Initial Date FDA Received: 05/08/2023
• Supplement Dates Manufacturer Received: 05/09/2023; 06/05/2023
• Supplement Dates FDA Received: 05/23/2023; 06/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2021
• 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