MAUDE Adverse Event Report: ETHICON INC. BLAKE SI DRAIN HBLS 10FR RND W/ 1/8IN; CATHETER, IRRIGATION

Catalog Number	2227
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 provided: the product because one product was received, but since the lot numbers on the two pouches are different, two lot numbers are listed.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 drain used on the patient? unk.If yes, was leakage detected? was another drain needed to correct the situation? unk.If yes, was the new drain placed surgically during a second procedure? unk.Could you please provide the lot number? unk.Could you kindly perform and document the follow-up attempt for the product return? furthermore, please ensure that the shipment tracking number is recorded in the notes or rmao sections.We regularly contact with sale rep about the device returning.Please provide the source or name of person providing answers to follow-up questions:(b)(6).H3 evaluation: complaint sample review: one complaint sample was received for evaluation; product was inspected visually and found that: 1.A transparent sticking mark on the trocar, nearby drain-trocar joint was visible.2.Also, a chip-off mark on the upper surface of the drain was visible while inspected under magnification.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: during investigation of complaint, batch review of in-process and final packaging inspections, as well as the manufacturing process is performed, these products are reported to be manufactured, inspected, and packaged in conformance with customer's specifications and have been found to be acceptable within all parameters.No discrepancy as per the reported defect is observed.Retention sample review: no negative observation was found.Review of defective sample's image / video: not applicable, as there was no complaint sample image / video received for evaluation.Additional information: d4, h4: the actual device lot number associated with this event is not known.Possible batch numbers are reported as follows: lot: j2402627: mfg date: 21-nov-2024, exp date: 21-nov-2029.Lot: j2402630: mfg date: 21-nov-2024, exp date: 21-nov-2029.A manufacturing record evaluation was performed for the possible finished device lots, and no non-conformance's were identified.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 procedure on an unknown date and a drain was used.It was found that the drain had adhered to the trocar needle.When separating them forcibly, the drain got a hole.Another product was used to complete the case.There were no adverse consequences to the patient.Further details are not provided.Upon receipt and analysis, a sticking mark on the trocar was visible and a chip-off mark on the upper surface of the drain.

• Brand Name: BLAKE SI DRAIN HBLS 10FR RND W/ 1/8IN
• 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: 24603870
• Report Number: 2210968-2026-02597
• Device Sequence Number: 15549627
• Product Code: GBX
• UDI-Device Identifier: 10705031003538
• UDI-Public: 10705031003538
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/16/2026

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: 2227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 03/16/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown