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 09/24/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).The following information has been requested and the following was received.To date the device has not been received.If the further details are received at a later date a supplemental medwatch will be sent.Was the new drain implanted during the same procedure or was a new surgery needed to implant 15fr drain? no further information is available.Was leakage detected? if so, where? no further information is available.Device return status: we regularly contact with sales rep about the device returning.No further information will be provided.

Event Description

It was reported a patient underwent a lumbar decompression surgery on (b)(6) 2020 and a drain was used.During surgery, the 10fr drain was placed in the epidural but negative pressure could not be applied.Another 15fr drain was used, then, negative pressure could be applied.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 fda: 1/27/2021.H3 evaluation: received one used drain pc2227.The drain is intact and functions properly.Analysis does not verify the reported failure.No non-conformities were obeservied in the received sample.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: 10734285
• MDR Text Key: 213024453
• Report Number: 2210968-2020-08326
• 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: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• 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: 11/09/2020
• Date Manufacturer Received: 01/06/2021
• Patient Sequence Number: 1