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

Device Problem Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Attempts to obtain the following information have been performed and was received.Did the reservoir function properly upon first activation? no further information is available.If no, how many reactivation were performed when issue was noticed? were the exit input caps loose? no further information is available.Was there a failure of the locking plate mechanism? no further information is available.How was the case completed? no further information is available.What is the lot number of the reservoir? no further information is available.What is the product code and lot number of the blake drain being returned? no further information is available.Device return status.We regularly contact with sales rep about the device returning.No further information will be provided.Attempts to obtain the device have been made.To date the device has not been received.If further details or the device are received at a later date a supplemental medwatch will be sent.Note: events reported via mw# 2210968-2020-04175.

Event Description

It was reported a patient underwent a robot-assisted laparoscopic prostatectomy on (b)(6) 2020 and a drain was used.After the procedure on (b)(6) 2020, it was unknown which caused the drainage issue.The lot number is unknown.Further details are not provided.There were no adverse consequences to the patient.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 6/8/2020.Additional information was provided: the product code is either: 2229 or 2233, however, we could not identify which was the correct product code.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 8/11/2020.Additional information: d10 correction: d2, d2b, g5.H3 evaluation: received one used 15fr drain, attached to the adapter.We inspected the drain visually, but no non-conformities were detected.Then we inspected the drain functionally, while its fluted part was immersed into a bowl filled with water.The drain was attached to the reservoir 100cc, and negative pressure was applied.The reservoir held the pressure properly and the drain functioned normally.There was no non-conformity detected in the received sample of the drain.The complaint is not verified.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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).Date sent to fda: 9/11/2020.

• Brand Name: BLAKE DRAIN UNKNOWN PRODUCT
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10093967
• MDR Text Key: 194789191
• Report Number: 2210968-2020-04174
• 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,Followup,Followup
• Report Date: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• 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: 06/24/2020
• Date Manufacturer Received: 08/17/2020
• Patient Sequence Number: 1