MAUDE Adverse Event Report: ETHICON INC. BLAKE SI DRAIN HBLS 24FR RND; CATHETER, IRRIGATION

Catalog Number	2234
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	04/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a patient underwent a coronary artery bypass and aortic valve replacement on (b)(6) 2025 and a drain was used.Hair found in the package of drain chest tube.No other details provided.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4) additional information: h6 component code: g07002 - device not returned.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.Response from the clinical user: the hair was found directly on the blake chest tube inside the sterile package.It was on the outermost coil towards the seal.I could see the hair on the drain as i started to open the interior package and i warned the scrub nurse not to touch it and moved away from the sterile field.The hair was approximately 1 inch in length and brown in color.It definitely came from inside the packaging.The seals for both the outer and inside package were intact.Please provide return shipping instructions.If a photo is sufficient, please let me know and we can try sending a photo.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: d9.H3 evaluation: 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.The product was kept in open pouch, the fact that it is mandate as per qms to maintain pouch integrity well with a proper product handling and storage, so that a complete holistic investigation can be completed.But was not case this time, and scope of investigation was very limited at our end.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.Complaint sample review: one complaint sample was received for evaluation, product was checked visually, below were detailed observations:1.Package was completely teared-off.2.One foreign particle-like hair inside the package and on the sealing area each, were observed.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 24FR RND
• 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: 22104879
• Report Number: 2210968-2025-05966
• Device Sequence Number: 8233023
• Product Code: GBX
• UDI-Device Identifier: 10705031003620
• UDI-Public: (01)10705031003620(11)240717(17)290717(10)J2401800
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

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: 2234
• Device Lot Number: J2401800
• 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: 05/01/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2024
• 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