MAUDE Adverse Event Report: ETHICON INC. BLAKE SI DRAIN HBLS 15FR RND W/ 3/16IN B; CATHETER, IRRIGATION

Catalog Number	2233
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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.Was the reservoir used with the adapter included with the corresponding blake drain? unk.What is the lot number of the jvac reservoir (2179) product involved? unk what is the lot number of the blake drain (2233) product involved? unk it has been reported that 6 reservoirs were involved.Please clarify, how many jvac reservoirs (2179) demonstrated the alleged deficiency?6.It has been reported that 6 reservoirs were involved.Please clarify, how many blake drains (2233) demonstrated the alleged deficiency?8 if six reservoirs and six drains were involved, were all involved over the same patient procedure? if not, please clarify how many patient procedures are involved and create one product complatin per each patient procedure.Unk please perform and document the follow up attempt for product return the device has been received at sukagawa and will be shipped.Please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq) (b)(6).Please confirm that 14 products were used during this one procedure with one patient: jvac reservoirs (2179) demonstrated the alleged deficiency? 6.Blake drains (2233) demonstrated the alleged deficiency? 8.What was the procedure? unk.Date of procedure? unk.Date of event? 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 an unknown surgery on an unknown date and a drain was used.The doctor pointed out that the connection was looser than other lots.The doctor also said that the connection was fixed with silk suture, but air still got sucked in.Same product was used to complete the case.There were no adverse consequences to the patient.Further details are not provided.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint #(b)(4).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 information: h6 component code.

• Brand Name: BLAKE SI DRAIN HBLS 15FR RND W/ 3/16IN B
• 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: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22731409
• Report Number: 2210968-2025-09137
• Device Sequence Number: 15674612
• Product Code: GBX
• UDI-Device Identifier: 10705031003613
• UDI-Public: 10705031003613
• 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,Followup
• Report Date (Section B): 09/30/2025

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 Catalogue Number: 2233
• 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: 07/09/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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