MAUDE Adverse Event Report: ETHICON INC. BLAKE (R) DRAIN 19FR R/F; CATHETER, IRRIGATION

Catalog Number	2230
Medical Device Problem Code	Break (1069)
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: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.H6 component code: g07002 - device not returned.Additional information provided: adverse consequences to the patient are unknown at this time, so it is being confirmed.·this event occurred during the surgery.·the roller for during emptying the reservoir was not used and the drain was broken during emptying the reservoir with cotton wool.·no additional procedures have occurred for the patient.·the doctor thinks that how to use was bad.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.Was the drain broken into two or more pieces? yes.Please perform and document the follow up attempt for product return.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) hiromi tokuyama.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 cardiovascular surgery on an unknown date and a drain was used.The drain was broken during emptying the reservoir during the surgery.The roller for during emptying the reservoir was not used and the drain was broken during emptying the reservoir with cotton wool.No additional procedures have occurred for the patient.The doctor thinks that how to use was bad.Further details are not provided.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: d9.H3 evaluation: complaint sample review: one complaint sample of drain in two parts, separated from the tubing area was received for evaluation, product was inspected visually below were detailed observation: 1.Drain was separated from the tubing area.2.While viewing the separation surface under magnification, multiple dents (including a deep mark) were observed on the perimeter of the drain.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.It is suspected that, separation surface of the drain might have came in contact with some pinned / sharp tool used prior / during surgery, and lead to the defect generation.External factors like mishandling or improper usage at user end could not be ruled out.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.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 (R) DRAIN 19FR R/F
• 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: 20668034
• Report Number: 2210968-2024-11904
• Device Sequence Number: 20659112
• Product Code: GBX
• UDI-Device Identifier: 10705031003583
• UDI-Public: 10705031003583
• 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): 01/14/2025

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: 2230
• 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: 10/21/2024
• Supplement Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 01/14/2025
• 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