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	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.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 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.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Additional information was requested, and the following was obtained: the product in question is unopened.The following information was requested but unavailable: please describe the type of foreign matter that was observed.What was the foreign matter¿s appearance? what was the texture? are there any photos of the foreign matter available?.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and a drain was used.It was found that there had been a foreign substance in the sterile package.The product in question was unopened.Another like product was used to complete the case.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 well intact package as complaint sample was received for evaluation, package was inspected visually (without tearing the packaging) and found that there was a foreign particle present inside the package.Hence, the complaint is justified at a thorough investigation was performed.Capa was identified by the manufacturer to address the event reported.The necessary investigations and/or actions have been taken to address the issue.During the investigation, a lot of hairs and fibbers were observed, inside or over the tyvek pouch surface received from supplier -.The reason for this was, supplier - didn't have a clean room facility for pouch manufacturing, which led to inclusion of hairs and fibbers inside or over the tyvek pouch surface.All the investigation outcomes were shared with and concluded to place a request to supplier for manufacturing the tyvek pouches inside the clean room facility.Accordingly, corrective action was summarised as still, the action is under progress at and a new capa is not required to be initiated.Documents review: during investigation of the complaint, batch review of in-process and final packaging inspections, as well as the manufacturing process was performed, these products were 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 was 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.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 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: 23896844
• Report Number: 2210968-2025-14591
• Device Sequence Number: 12098274
• Product Code: GBX
• UDI-Device Identifier: 10705031003606
• UDI-Public: (01)10705031003606(17)300320(10)J2500320
• 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,Followup
• Report Date (Section B): 02/20/2026

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
• Device Lot Number: J2500320
• 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: 12/09/2025
• Supplement Date Received by Manufacturer: 12/09/2025; 02/09/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 12/26/2025; 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2025
• 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