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

Catalog Number	2232
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 provided: -the drain after reinforcement could be used.-it have not particularly heard of any effects on the patient, such as a worsening of their condition.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.Did the drain come in contact with surgical instruments, surgical needles, sutures, sharp objects at any time?=>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 sukagawa and will be shipped.Please check rmao.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).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.The drain was damaged and leaked fluid when suctioned.As this was found outside the operating room, the lot number is unknown, but the damaged area was reinforced with covering material and the product was used.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 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 information: d9, h3, h6.Additional h3 investigation summary: complaint sample review: one complaint sample of drain in two parts (separated from tubing area) without any trocar was received for evaluation; product was checked visually and found that there were significant pinned / cut marks visible on the separation surface of the drain.Since, the silicone elastomer suction drain tubing is soft and pliable.It should not be handled or come into contact with pointed toothed, sharp-cornered, or even blunt instruments, as punctures, surface cuts, nicks, crushing or other overstressing can lead to tearing or warping of the tubing and to subsequent structural failure of the drain and/or fragment retention within the wound.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.Due to the damages found on the device the complaint was confirmed.Even though the condition is confirmed it is found not justified since the assignable cause for the condition is not related to the manufacturing process within manufacture control.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.Device history review: not applicable as lot number of the complaint was unknown, hence, batch history review was not performed.

• 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: 23096014
• Report Number: 2210968-2025-10734
• Device Sequence Number: 8686156
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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: 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: 08/27/2025
• Supplement Date Received by Manufacturer: 10/05/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 10/17/2025
• 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