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

Model Number	2230
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: (b)(4) device not returned.Additional information was requested and received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.Procedure name? no further information is available.Procedure date? no further information is available.Date of removal of drain? no further information is available.Were there any anomalies with the drain: appearance, damage or function? no further information is available.How was the drain secured? no further information is available.Where was the drain placed? no further information is available.Was the drain checked for patency during the procedure? no further information is available.Did the drain function as intended? after the surgery, the drain was clogged at the starting point of the groove on the drain.Lot number of the drain? no further information is available.What is the surgeon¿s opinion of the impact of the drain on the patient consequences? no further information is available.Patient¿s current status? no further information is available.
Event or Problem Description
It was reported a patient underwent an unknown cardiovascular surgery on an unknown date a drain was used.The drain was clogged at the starting point of the groove on the drain, and cardiac tamponade developed.Re-thoracotomy was performed.Further details are not provided.No sample will be returned.Additional information has been requested.

• Brand Name: BLAKE (R) DRAIN 19FR R/F
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12040394
• Report Number: 2210968-2021-05722
• Device Sequence Number: 3503367
• Product Code: GBX
• UDI-Device Identifier: 10705031003583
• UDI-Public: 10705031003583
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2230
• Device Catalogue Number: 2230
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 06/22/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention