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 01/05/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # : (b)(4).If it is reported that the device will not be returned at this time/not available: if further details are received at a later date a supplemental medwatch will be sent.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 an unknown orthopedic surgery on (b)(6) 2021 and a drain was used.There was a damaged point on the drain outside the patients body, and blood leaked out.The event occurred after the wound was closed after surgery but before the patient was taken out to the ward.The drain was continuously used.Then the drain was removed and discarded.Further details are not provided.No sample will be returned.There were no adverse consequences to the patient.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to fda: 3/2/2021.H3 evaluation: complaint sample was not received from the customer for evaluation.However, complaint sample photograph was received for analysis but on the basis of photograph il can not be corelate the leakage due to manufacturing process, retain sample of the same lot no j1924386 were checked visually and found within the specified criteria there was no hole.Damage or crack on the drain.There was not any damaged drain from the outside observed.The complaint sample was not available for evaluation.However, the photograph of product complaint (leakage) was provided but on the basis of photograph il cannot be determine the drain damage in manufacturing process.There was not enough information to delermine the root cause.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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: 11241121
• MDR Text Key: 229528480
• Report Number: 2210968-2021-00738
• 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: 01/07/2021

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
• Device Lot Number: J1924386
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA Received: 01/27/2021
• Supplement Dates Manufacturer Received: 02/11/2021
• Supplement Dates FDA Received: 03/02/2021
• Patient Sequence Number: 1