MAUDE Adverse Event Report: ETHICON INC. 24 FR RD BLAKE HBLS SILC; CATHETER, IRRIGATION

Model Number 2234

Device Problem Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).To date the device has not been received.If further details or the device are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported a patient an unknown cardiovascular surgery on (b)(6) 2020 and a drain was used.During surgery the drain was clogged though it was new.The lot number is unknown.Further details are not provided.No sample will be returned.There were no adverse consequences to the patient.

Manufacturer Narrative

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

• Brand Name: 24 FR RD BLAKE HBLS SILC
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10094295
• MDR Text Key: 198304327
• Report Number: 2210968-2020-04188
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003620
• UDI-Public: 10705031003620
• 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: 05/22/2020

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
• Device Operator: Health Professional
• Device Model Number: 2234
• Device Catalogue Number: 2234
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/22/2020
• Initial Date FDA Received: 05/27/2020
• Supplement Dates Manufacturer Received: 08/17/2020
• Supplement Dates FDA Received: 09/14/2020
• Patient Sequence Number: 1