MAUDE Adverse Event Report: ETHICON INC. BLAKE SI DRAIN HBLS 15FR RND; CATHETER, IRRIGATION

Catalog Number	2228
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a patient underwent an unknown procedure on (b)(6) 2023 and a drain was used."mct bubbling, not draining, removed and hole in tubing found ".No other details provided.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint (b)(4) additional information: h6 component code: g07002 - device not returned additional information has been requested however not received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.What is the lot number? did the drain come in contact with surgical instruments, surgical needles, sutures, sharp objects at any time? how was the case completed? was a new drain needed to be implanted during a secondary procedure? is the device available to be returned for evaluation? if so, please provide the status of the return and any available tracking information.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: b 1.Is adverse event, b 2.Is required intervention, h1, h6.Health effect - clinical code, h6.Health effect - impact code.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.What is the lot number? not recorded.Did the drain come in contact with surgical instruments, surgical needles, sutures, sharp objects at any time? no.How was the case completed? using a new product.Was a new drain needed to be implanted during a secondary procedure? yes.Is the device available to be returned for evaluation? if so, please provide the status of the return and any available tracking information.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Corrected information: b 1.Is adverse event, b 2.Is required intervention, h6.Health effect clinical code, h6.Health effect - impact code.Additional information has been requested and received.If further details are received at a later date a supplemental medwatch will be sent.This happened a while ago, we will have to check if any further details can be retrieved.Appropriate procedure would have been done at time of incident.Was another product used? no.Was a new drain replaced during the initial procedure on (b)(6) 2023? or was there another procedure required to replace the reported drain? it does not appear that a new drain was placed.If yes, on what date was the new drain placed?na.How was the new drain placed? na.Was a surgical procedure required to place the new drain? na.What type of procedure what the device used in? na.What was the patient outcome post procedure? na.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.

• Brand Name: BLAKE SI DRAIN HBLS 15FR 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 12205 2; IN 122052
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19176966
• Report Number: 2210968-2024-04822
• Device Sequence Number: 3727579
• Product Code: GBX
• UDI-Device Identifier: 10705031003569
• UDI-Public: 10705031003569
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2024

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 Catalogue Number: 2228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2024
• Supplement Date Received by Manufacturer: 05/01/2024; 05/30/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 05/29/2024; 06/24/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown