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 05/26/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information was requested and received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.What is the lot number? no further information is available.Drain/unk, reservoir (b)(4).Did the drain come in contact with surgical instruments, surgical needles, sutures, sharp objects at any time? no further information is available.How was the case completed? because there was almost no bleeding, the drain was removed, and the operation was completed without drain.No further information is available.Device return status: we regularly contact with sales rep about the device returning.No further information will be provided.Note: events reported on mw# 2210968-2021-05733.

Event Description

It was reported a patient underwent a total hip arthroplasty on (b)(6) 2021 and a drain was used.The drain was placed, and suction was started, but the reservoir immediately swelled, and blood could not be sucked.Suction became poor, so when checking the drain carefully, it seemed that there had been a scratch on the drain, and there had been an air leak.Further details are not provided.There were no adverse consequences to the patient.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 8/24/2021.Additional information: d9, h6 component code: g07002 reported condition not confirmed.H3 evaluation: one used sample of drain was received for evaluation.The visual inspection of drain was done and there were no scratch marks observed on the drain.Leak test of drain was also performed to verify for any hole/cut marks but no leak observed.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 08869
• MDR Report Key: 12041717
• MDR Text Key: 268295874
• Report Number: 2210968-2021-05732
• 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: 05/28/2021

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: 07/21/2021
• Initial Date Manufacturer Received: 05/28/2021
• Initial Date FDA Received: 06/22/2021
• Supplement Dates Manufacturer Received: 08/11/2021
• Supplement Dates FDA Received: 08/24/2021
• Patient Sequence Number: 1