MAUDE Adverse Event Report: ETHICON INC. BLAKE DRAIN UNKNOWN PRODUCT; CATHETER, IRRIGATION

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

Manufacturer Narrative

Complaint #: (b)(4).The following information has been requested and obtained.To date the device has not been received.If the further details are received at a later date a supplemental medwatch will be sent " where was leakage observed (drain or reservoir)? no further information is available." what is the lot number of the drain? no further information is available." did the drain and reservoir function properly upon first activation? no further information is available." how long was the device used before the issue occurred? no further information is available." was another reservoir used to correct the situation? no further information is available." was another drain used to correct the situation? no further information is available." if another drain was needed, was it placed during a second surgery? " device return status: the device has been received at (b)(4) and will be shipped.Please check rmao.No further information will be provided.Note: events reported on mw# 2210968-2020-09907 and mw# 2210968-2020-09908.

Event Description

It was reported a patient underwent an unknown procedure on (b)(6) 2020, and a drain was used.While drainage was being done in the ward, suction was not done properly, and leakage occurred.Further details are not provided.There were no adverse consequences to the patient.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 5/10/2021.H3 evaluation: complaint sample was received from the customer for evaluation.After opening of complaint sample, drain was received, however, the bulb port was broken as per complaint but the sample of bulb was not found as complaint sample.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: 5/10/2021.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 DRAIN UNKNOWN PRODUCT
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 11009416
• MDR Text Key: 221528027
• Report Number: 2210968-2020-09908
• Device Sequence Number: 1
• Product Code: GBX
• 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: 11/23/2020

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Initial Date Manufacturer Received: 11/23/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 04/13/2021
• Supplement Dates FDA Received: 05/10/2021
• Patient Sequence Number: 1