MAUDE Adverse Event Report: ETHICON INC. BLAKE (R) DRAIN 15FR ROUND; CATHETER, IRRIGATION

Model Number 2228

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? the image does not include the lot number.Could this possibly be from old inventory at the customer? was this from stock at a customer or a from a (b)(4) (sales rep, warehouse)? 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.

Manufacturer Narrative

Product complaint # (b)(4).The following information was requested and obtained: i received the image of nurse , responsible for the surgical center of hospital copa star.I don't have the device lot number specifically.When you refer to an "old stock", how long is this period? the reason of the question is that the hospital copa star was opened about 3 years ago.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 4/22/2020.Corrected information: d3, g1, g2.H3 evaluation: product not returned for analysis.The information about the product containing latex/ and 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 15FR ROUND
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9676174
• MDR Text Key: 195116762
• Report Number: 2210968-2020-00976
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003569
• UDI-Public: 10705031003569
• 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,Followup
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2228
• Device Catalogue Number: 2228
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2020
• Patient Sequence Number: 1