MAUDE Adverse Event Report: ETHICON INC. BLAKE; CATHETER, IRRIGATION

Catalog Number	2216
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) 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.Where was the foreign material found? (inside the sterile barrier or outside of the sterile barrier?)unk please describe the type of foreign matter that was observed.What was the foreign matter¿s appearance? what was the texture?unk,color is black are there any photos of the foreign matter available?yes is it possible that the foreign material fell into packaging upon opening of device?unk was the product seal on the foil still intact when the package was opened?unk will the device be returned for evaluation? if yes please return all relevant packaging material.The device will be shipped.Please check rmao.Was the procedure completed without any adverse effect to the patient?unk could you please provide the lot number? j2403015 please provide the source or name of person providing answers to follow-up questions: (b)(6).H3 evaluation: a total of six (06) images of the suspected defective product, for which, following photo analysis is completed.From the photographs whether the foreign matter is free-lying or embedded within the product.Received pictures are checked visually, and concluded that: photo- att27046: product is visible in inner pouch with lot number ¿j2403015¿ and product code ¿2216¿ also open outer pouch with label visible.Photo- att64605: without product pouch visible with label.Photo- att67163: product is visible, pouch already open.Photo- ax20: blackish matter is visible on tyvek side of pouch.Photo- bx100: its looks like zoomed view of black-colored substance, dirt, or particles seen on the tyvek side of the packaging pouch.Photo- cx100: its looks like zoomed view of black-colored dirt visible.Conclusion: based on the visual review of the received images, the presence of foreign matter on the pakage is observed.However, it is unclear from the photographs whether the foreign matter is free-lying or embedded within the product.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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 in (b)(6) 2026 a suture was used.It was found that there was a foreign matter in the package.The product was not used.This event was found before use.Another product was used to complete the case.There were no adverse consequences to the patient.Further details are not provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: d9.H3 evaluation: complaint sample review : one complaint sample of drain with trocar was received for evaluation, product was inspected visually and in reference to the complaint details -no foreign matter was found.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 :photo-analysis of the pictures received against the complaint, already reported.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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
• 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: 24674802
• Report Number: 2210968-2026-03002
• Device Sequence Number: 10331107
• Product Code: GBX
• UDI-Device Identifier: 10705031003521
• UDI-Public: (01)10705031003521(17)291111(10)J2403015
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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: 2216
• Device Lot Number: J2403015
• 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: 02/24/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2024
• 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