MAUDE Adverse Event Report: ETHICON INC. BLAKE SI DRAIN HBLS 19FR RND W/ 1/4IN BNDBLE TR; 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)
Date of Event	01/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #:(b)(4).Additional information: h6 component code: g07002 - device not returned attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.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 (b)(6) 2025 and a drain was used.After opening the sterile package, it was confirmed that the human hairs were wound around the drain.The product was not used for the patient.Another product was used to complete the case.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).Additional information: h6 component code: g07002 - device not returned.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.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: complaint sample review: one complaint sample of drain and trocar with teared-off package was received for evaluation, product was inspected visually and a hair was found on the drain.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: not applicable, as there was no complaint sample image / video received for evaluation.As the package of the drain was in teared-off condition, and we are well aware with the fact that for such defect justification, package integrity (i.E.Original condition) is required, so scope of the investigation is very limited at our end.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.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 BNDBLE TR
• 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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21358259
• Report Number: 2210968-2025-01575
• Device Sequence Number: 8482143
• Product Code: GBX
• UDI-Device Identifier: 10705031003606
• UDI-Public: (01)10705031003606(11)250417(17)290417(10)J2400787
• 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,Followup
• Report Date (Section B): 04/18/2025

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
• Device Lot Number: J2400787
• 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: 01/22/2025
• Supplement Date Received by Manufacturer: 02/11/2025; 03/20/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 03/10/2025; 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2024
• 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