MAUDE Adverse Event Report: ETHICON INC. BLAKE (R) DRAIN 10FR ROUND; CATHETER, IRRIGATION

Model Number 2227

Device Problem Leak/Splash (1354)

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

Event Date 02/10/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Additional information has been requested and obtained.To date the device has not been received.If further details are received at a later date a supplemental medwatch will be sent.No further information is available.What is the lot number? no further information is available.Was another drain needed to correct the situation? no further information is available.If yes, was the new drain placed surgically during a second procedure? device return status.We regularly contact with sales rep about the device returning.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 orthopedic surgery on (b)(6) 2021 and a drain was used.During surgery, soon after inserting the drain to the patient, the reservoir swelled, so when checking them, there was a hole on the drain.The drain was not fixed with the suture yet, so it is unlikely that it was hurt during the operation.Further details are not provided.There were no adverse consequences to the patient.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 6/8/2021.H3 evaluation: complaint sample was received.After opening the complaint sample primary pack, it was observed that there was a small piece of drain.The complaint sample (drain) was not in original its length.The actual length of drain is 1200mm however, the size of complaint drain was 300mm.The complaint sample photograph was received for analysis but on the basis of photograph it can not be corelate the leakage due to manufacturing process.Evaluation of retain sample was not done as the lot number is not specified.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.Product complaint # (b)(4).Date sent to the fda: 6/8/2021.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 (R) DRAIN 10FR ROUND
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 11406248
• MDR Text Key: 234773377
• Report Number: 2210968-2021-01937
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003552
• UDI-Public: 10705031003552
• Combination Product (y/n): N
• PMA/PMN Number: CL I EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/17/2021

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: 2227
• Device Catalogue Number: 2227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Initial Date Manufacturer Received: 02/17/2021
• Initial Date FDA Received: 03/03/2021
• Supplement Dates Manufacturer Received: 05/18/2021
• Supplement Dates FDA Received: 06/08/2021
• Patient Sequence Number: 1