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

Model Number 2226

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Attempts to obtain the following information have been made with no response to date.If the device or further details are received at a later date a supplemental medwatch will be sent.What is the lot? could this possibly be from old inventory at the customer? 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.

Event Description

It was reported that a drain product received was noted to include product labeling to have an incorrect warning label concerning the presence of latex in the drain.The labeling contains a warning stating it contains latex when, in fact, it does not.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 4/28/2020.Corrected information: d3, g1, g2.Attempts to obtain the following information has been performed and the following was received: with regard to copa dor, i do not believe that the drains are of old stock.There is a consumption that leads us to believe that the stock is renewed.H3 evaluation: product not returned for analysis.The information about the contain latex/ does not contain latex was correct, only the labels in system were incorrect.The quality issue number is 1721045 and it is registered.The label was corrected just on (b)(6) 2020 in distribution center system.This was believed to have been corrected before.Action will be addressed to correct label.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to fda: 9/14/2020.

• 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
• MDR Report Key: 9686891
• MDR Text Key: 195416791
• Report Number: 2210968-2020-01050
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003545
• UDI-Public: 10705031003545
• 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: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2226
• Device Catalogue Number: 2226
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2020
• Patient Sequence Number: 1