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

Model Number	2234
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 9/14/2020.

• Brand Name: 24 FR RD BLAKE HBLS SILC
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10094295
• Report Number: 2210968-2020-04188
• Device Sequence Number: 3182516
• Product Code: GBX
• UDI-Device Identifier: 10705031003620
• UDI-Public: 10705031003620
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 2234
• Device Catalogue Number: 2234
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2020
• Supplement Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 05/27/2020
• Supplement Report FDA Received Date: 09/14/2020
• Patient Sequence Number: 1