MAUDE Adverse Event Report: ETHICON INC. BLAKE SI DRAIN HBLS 19FR RND; 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
Event or Problem Description
It was reported a patient underwent an unknown procedure on an unknown date and a drain was used.The drain was cut off outside the body.Gauze was applied and milking was performed manually, but no milking rollers or other instruments were used.Further details are not provided.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4) additional information: h6 component code: g07002 - device not returned additional information has been requested however not 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? ¿ was the drain inadvertently broken into two or more pieces? or did the user cut the drain to achieve drainage? ¿ two products were reported to be involved under (b)(4), but the event description suggests that only one drain was cut off.Please clarify how many drains were involved in this case, and how many drains were cut off.¿ if two drains were involved but only one was cut off, please clarify if there any product quality issues regarding the second drain.¿ how was the case completed? ¿ please perform and document the follow up attempt for product return.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 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 ¿ was the drain inadvertently broken into two or more pieces? or did the user cut the drain to achieve drainage?=>unk ¿ two products were reported to be involved but the event description suggests that only one drain was cut off.Please clarify how many drains were involved in this case, and how many drains were cut off.=>two products were broken in this case.¿ if two drains were involved but only one was cut off, please clarify if there any product quality issues regarding the second drain.=>two products had the same isssues ,which were broken in this case.¿ how was the case completed?=>unk ¿ please perform and document the follow up attempt for product return.=>we regularly contact with sales rep about the device returning.Note: events reported via: mw# mwr-24082023-0001468509 mw# 2210968-2023-07427.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: one complaint sample of drain of around 200 mm was received for evaluation, product was inspected visually and found that there was a deep cut mark on one side of the drain.Retention sample is not checked, as lot no.Of the complaint is unknown.During investigation of the complaint, batch manufacturing record and retained sample review could not performed, as the lot number of the complaint was unknown.It is suspected that, drain might have come in contact with some 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, visually.Before and after packing of finished goods, prior to the product release.So, 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 SI DRAIN HBLS 19FR 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 ; IN
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17702028
• Report Number: 2210968-2023-06476
• Device Sequence Number: 15126167
• 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,Followup
• Report Date (Section B): 11/14/2023

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: 08/23/2023
• Supplement Date Received by Manufacturer: 09/11/2023; 10/29/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 10/04/2023; 11/14/2023
• 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