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

Model Number	2228
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional Manufacturer Narrative
(b)(4).Additional information: d4, h4, h6 the device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 4/28/2020.Corrected information: d3, g1, g2.Additional information: d4.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 (b)(4) 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.
Additional Manufacturer Narrative
Product complaint (b)(4).Date sent to fda: 9/14/2020.

• Brand Name: BLAKE (R) DRAIN 15FR ROUND
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9687137
• Report Number: 2210968-2020-01049
• Device Sequence Number: 3203961
• Product Code: GBX
• UDI-Device Identifier: 10705031003569
• UDI-Public: 10705031003569
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: CL I EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/14/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 2228
• Device Catalogue Number: 2228
• Device Lot Number: J1834955
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 04/01/2020; 06/17/2020; 08/17/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 04/28/2020; 06/22/2020; 09/14/2020
• Patient Sequence Number: 1