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

Model Number 2227

Device Problem Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Attempts to obtain the device have been made.To date the device has not been received.If the further details are received at a later date a supplemental medwatch will be sent.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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 breast implant inclusion surgery on (b)(6) 2020 and a drain was used.It was noted when separating materials, surgical assistant noticed a thin and dark" hair inside drain packaging still in sterile packaging.No reported patient consequences.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 4/19/2021.Corrected data: d3.Additional information: d9.H3 evaluation: the complaint sample was received.When sample packed was opened, no foreign particle/hair found inside the packaging.Retain sample of the same lot no.J1841327 were checked visually and found within the specified criteria.There was no foreign particle/hair inside the package.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 product complaint # (b)(4).Date sent to the fda: 4/19/2021.Corrected data: d3, g1.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 08876
• MDR Report Key: 11048226
• MDR Text Key: 226655617
• Report Number: 2210968-2020-10129
• 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: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2023
• Device Model Number: 2227
• Device Catalogue Number: 2227
• Device Lot Number: J1841327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2021
• Date Manufacturer Received: 04/14/2021
• Patient Sequence Number: 1