MAUDE Adverse Event Report: ETHICON INC. BLAKE (R) DRAIN 19FR R/F; CATHETER, IRRIGATION

Model Number 2232

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: please verify, did the label of the outer or secondary packaging of this device had lot number j1702661 and upon opening the lot number on the primary package had a different lot j1704906.=> yes.The outer pakcage was for 11232 (thus, 2232) with lot # j1702661.The primary (inner) package was for 11233 (thus, 2233) with lot # j1704906.Are pictures available to depict the issue? => no.Was the product properly sealed when issue was discovered and there is no possibility of it been tampered? => yes.The product was properly sealed when the issue was discovered.

Event Description

It was reported that during an unknown procedure on (b)(6) 2018, drain was to be used.It was found that the outer package and inner product did not match.There were no adverse consequences to the patient.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to fda: 8/31/2020.

• Brand Name: BLAKE (R) DRAIN 19FR R/F
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7297718
• MDR Text Key: 101127618
• Report Number: 2210968-2018-71058
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003606
• UDI-Public: 10705031003606
• 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
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2232
• Device Catalogue Number: 2232
• Device Lot Number: J1702661
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1