MAUDE Adverse Event Report: ETHICON INC. BLAKE SI DRAIN HBLS 19FR RND W/ 1/4IN BN; CATHETER, IRRIGATION

Catalog Number	2232
Medical Device Problem Codes	Leak/Splash (1354); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
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 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.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested, and the following was obtained: suction could not be done well as usual.According to the nurse, the groove of the drain, which is usually placed inside the abdominal cavity, was outside the abdomen, so suction might not have worked properly.The hospital asked to check whether there was any damage to the reservoir or the drain.They said that if there is no problem with the product, it was likely a handling error on their side.No surgical procedure, such as placing the drain again, was performed.Additional information was requested, and the following was obtained: what is the lot number? ju1228.Was the reservoir used with the adapter included with the corresponding blake drain? unk.Were any issues associated to the blake drain involved? unk.If yes, please provide product code and lot number of the blake drain involved? unk.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2025 and a drain was used.Post-op at the wards/icu, the drain came off from the reservoir.The suction also could be felt difficult and the suction could not be done well, as usual.According to the nurse, the groove of the drain, which is usually placed inside the abdominal cavity, was outside the abdomen, so suction might not have worked properly.The hospital asked to check whether there was any damage to the reservoir or the drain.They said that if there is no problem with the product, it was likely a handling error on their side.There was no surgical procedure, such as placing the drain again, was performed.There were no adverse consequences to the patient.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: d9.H3 evaluation: complaint sample review : one complaint sample of drain without any trocar and with pre-attached adapter was received for evaluation, product was inspected visually and functionally and in reference to the complaint.No negative observation was found (video of suction test attached for reference).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.It is inconclusive the cause.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.

• Brand Name: BLAKE SI DRAIN HBLS 19FR RND W/ 1/4IN BN
• 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: 23706115
• Report Number: 2210968-2025-13532
• Device Sequence Number: 10649525
• Product Code: GBX
• UDI-Device Identifier: 10705031003606
• UDI-Public: 10705031003606
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2026

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: 2232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 03/04/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown