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

Model Number 2227

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: was a cut/slit actually noticed on the drain? => no, it wasn¿t.How was the case completed? => the drain was replaced to a new drain.Was the drain surgically removed and a new drain placed in the patient? the drain was replaced to a new drain, however, it is not unknown if the drain was surgically removed.No further information will be provided.".

Event Description

It was reported that a patient underwent an unknown otolaryngology-head and neck surgery and a drain was placed.After the procedure, air leakage occurred through the drain.The reservoir was swelled at that time.There is a possibility that there had been a hurt or a hole on the drain before use.The drain was replaced to another new one.There were no adverse consequences to the patient.

Manufacturer Narrative

(b)(4).Evaluation: received one used drain.Visual inspection performed, there is a cut hole on the drain.The drain may have been damaged during its use.The issue was not due to manufacturing defect.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to fda: 9/1/2020.

• 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 0151
• MDR Report Key: 7511449
• MDR Text Key: 108195700
• Report Number: 2210968-2018-72783
• 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,Followup
• Report Date: 04/17/2018

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 Expiration Date: 04/22/2022
• Device Model Number: 2227
• Device Catalogue Number: 2227
• Device Lot Number: J1703165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Initial Date Manufacturer Received: 04/17/2018
• Initial Date FDA Received: 05/14/2018
• Supplement Dates Manufacturer Received: 07/11/2018; 08/17/2020
• Supplement Dates FDA Received: 07/16/2018; 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1