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

Catalog Number	2229
Medical Device Problem Code	Material Integrity Problem (2978)
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: 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.What is the lot number? unk.Was the drain used on the patient? unk.If yes, was leakage detected? was another drain needed to correct the situation? yes.If yes, was the new drain placed surgically during a second procedure? unk.Please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.The device has been received at (b)(6) and will be shipped.Please check rmao.Tracking number: (b)(4).Please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep) kana takahashi h3 evaluation: complaint sample review : one complaint sample of drain with trocar was received for evaluation, product was inspected visually:1.No sticking mark was identified on trocar.2.Drain had a chip-off mark on upper surface.As per standard practice, 100% functional test and 100% visual inspection was carried out, before and after packing of finished goods, prior to the product release.There was no scope to miss such defect, at manufacturing / release stage.Documents review : not applicable, as lot number of the complaint was unknown, hence, batch history review was not performed.Retention sample review : not applicable, as lot number of the complaint was unknown, hence, retention sample review was not performed.Review of defective sample's image / video : not applicable, as there was no complaint sample image / video received for evaluation.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 plastic surgery on an unknown date in 2025 and a drain was used.The drain had adhered to the trocar needle when the product was opened and taken out in the operation room and use was stopped.Another product was used to complete the case.There were no adverse consequences to the patient.Further details are not provided.Upon receipt and evaluation it was observed drain had a chip-off mark on upper surface.

• Brand Name: BLAKE SI DRAIN HBLS 15FR RND W/ 3/16IN T
• 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: 22871685
• Report Number: 2210968-2025-09665
• Device Sequence Number: 12184914
• Product Code: GBX
• UDI-Device Identifier: 10705031003576
• UDI-Public: 10705031003576
• 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): 08/22/2025

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: 2229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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