MAUDE Adverse Event Report: ETHICON INC. BLAKE SI DRAIN HBLS 24FR RND; CATHETER, IRRIGATION

Model Number	2234
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not received.Additional information has been 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.Qty of product involved : 3 => 1.What is the lot number of each involved device?=> unk.Please clarify, were three (3) blake drains 2234 involved over the same procedure? =>no, over three procedures.Only 1 product was used on this procedure.(qty of product involved of this surgery was changed from 3 to 1.) the other 2 were registered.Did all involved products fail to drain?=> suction could not be done properly.Was the issue in regards to the drain or the reservoir? => drain.If the affected device was the reservoir, please provide product code and lot number of the involved reservoir.Was another drain needed to correct the situation? => unk.Was a new drain placed surgically during a second procedure? => unk.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported a patient underwent a pancreaticoduodenectomy on (b)(6) 2023 and a drain was used.In the ward / icu, suction could not be done properly.Further details are not provided from the hp.No sample will be returned.There were no adverse consequences to the patient.Additional information has been requested.

• Brand Name: BLAKE SI DRAIN HBLS 24FR RND
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): DEGANIA INDIA; 251, sector-6, imt manesar; gurugram ; IN
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16828095
• Report Number: 2210968-2023-03068
• Device Sequence Number: 7125150
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/27/2023

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown