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 04/14/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Attempts to obtain the device however not received.If 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 an unknown cardiovascular surgery on (b)(6) 2021 and a drain was used.During surgery, when suction was applied after the drain was placed under the sternum, a gurgling sound was heard, and air leak was observed.Visually, two pinholes were found to be open.There was no action that damages the drain from removal to use.Use was stopped and the surgery was completed with a new one.Further details are not provided.There were no adverse consequences to the patient.

Manufacturer Narrative

Product complaint # (b)(4)date sent to the fda: 7/12/2021 additional information: d9 h3 evaluation: complaint sample was received for evaluation.After opening the complaint sample primary pack, there were two pieces of used drains.The complaint sample (drain) was not in original its length.The actual length of drain is 1200mm however, the size of complaint drain was about 300mm and 330mm respectively.On the basis of sample received actual leak /pinhole in the can not be determined.During the batch record review of the complaint lot j2003933, there was no nonconformity detected in the process.The complaint sample was available for investigation but the sample was broken in two pieces, it doesn¿t corelate with the complaint hole in drain/leak.The drain could be damaged during the use.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, 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: 11809010
• MDR Text Key: 250073482
• Report Number: 2210968-2021-04451
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 04/16/2021

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: J2003933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Initial Date Manufacturer Received: 04/16/2021
• Initial Date FDA Received: 05/11/2021
• Supplement Dates Manufacturer Received: 06/30/2021
• Supplement Dates FDA Received: 07/12/2021
• Patient Sequence Number: 1