MAUDE Adverse Event Report: ETHICON INC. BLAKE DRAIN UNKNOWN PRODUCT; CATHETER, IRRIGATION

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/03/2023

Event Type  malfunction  

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."¿ what is the lot number?=>unk ¿ how was the case completed? unk ¿ was another drain needed to correct the situation? =>unk ¿ please perform and document the follow up attempt for product return.=>we regularly contact with sales rep about the device returning.Additional information has been requested however not received it was noted the leak was confirmed.In the reservoir? both reservoirs? what is the reported issue with the drain if the leak was discovered in the reservoir(s)? ¿ if yes, was the new drain placed surgically during a second procedure? note: events reported via: mw#2210968-2023-07486, mw# 2210968-2023-07487, mw# 2210968-2023-07489.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 Description

It was reported a patient underwent an unknown procedure on (b)(6) 2023 and a drain was used.On (b)(6) 2023 a leak was confirmed.Further details are not provided.There were no adverse consequences to the patient.Additional information has been requested.

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.It was noted the leak was confirmed.In the reservoir? both reservoirs? reservoir.What is the reported issue with the drain if the leak was discovered in the reservoir(s)? unk.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.

Manufacturer Narrative

Product complaint # (b)(4).H3 evaluation: complaint sample review : complaint sample of drain were received for evaluation, no non-compliance was observed during visual inspection.Also, both the samples were checked functionally and found ok.Retention sample is not checked, as lot no.Of the complaint is unknown.During investigation of the complaint, bmr and retained sample review could not performed, as the lot number of the complaint was unknown.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, viz.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 DRAIN UNKNOWN PRODUCT
• Type of Device: 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: 17885431
• MDR Text Key: 325078226
• Report Number: 2210968-2023-07488
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: CL I EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/25/2023
• Initial Date FDA Received: 10/06/2023
• Supplement Dates Manufacturer Received: 10/27/2023; 11/20/2023
• Supplement Dates FDA Received: 11/17/2023; 12/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1