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

Model Number 2227

Device Problem Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/16/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Attempts to obtain the following information and the following was received.Attempts have also been made to obtain the device.To date the device has not been returned.If further details are received at a later date a supplemental medwatch will be sent.Was the connection issue noticed before activating the reservoir? no further information is available.Did the reservoir function properly upon first activation? no further information is available.On what day post operative did the reservoir stop functioning? no further information is available.Was another reservoir used to fulfill need of drainage? no further information is available.Device return status we regularly contact with sales rep about the device returning.No further information will be provided.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 a knee joint surgery on (b)(6) 2020 and a drain was used.Post operatively, on the ward, the connection part was loose and drainage was not achieved.Further details are not provided.There were no adverse consequences to the patient.

Manufacturer Narrative

Product complaint # (b)(4).Evaluation: received one used 10fr blake drain and the adapter for attachment to suction reservoir.The adapter matches the specification, this code of adapter is supplied with 10fr blake drains.The received sample was evaluated and found conforming to the specification.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.

• Brand Name: BLAKE (R) DRAIN 10FR ROUND
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10268125
• MDR Text Key: 198698465
• Report Number: 2210968-2020-05243
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003552
• UDI-Public: 10705031003552
• Combination Product (y/n): N
• PMA/PMN Number: K953655
• 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: 07/01/2020

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
• Device Model Number: 2227
• Device Catalogue Number: 2227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Initial Date Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 07/13/2020
• Supplement Dates Manufacturer Received: 08/12/2020
• Supplement Dates FDA Received: 08/24/2020
• Patient Sequence Number: 1