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

Device Problem Infusion or Flow Problem (2964)

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

Event Date 09/16/2022

Event Type  malfunction  

Event Description

It was reported a patient underwent an unknown procedure on (b)(6) 2022 and a drain was used.In the ward/icu, the drain would not function.Further details are not provided.There were no adverse consequences to the patient.

Manufacturer Narrative

Product complaint # (b)(4).Additional information: the customer regarded the drain and reservoir as ¿one drainage system.¿ thus, it regarded this issue as an ¿issue with the system.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.Did the two reservoirs (ju0346 and ju0564) fail to lock over the same patient event? no further information is available.If no, please clarify how many reservoirs failed and in how many patient procedures.Device return status: the device has been received at (b)(4) and will be shipped.Please check rmao.No further information will be provided.Note: events reported on mw# 2210968-2022-08236, mw# 2210968-2022-08237.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).Date sent to the fda: 11/29/2022.H3 evaluation: one used drain sample received for evaluation.Reservoir which was used during surgery not available for evaluation.Upon visual inspection of returned drain sample, no discrepancy and/or blockage found in drain.Functionality test of drain was performed with 100 ml reservoir and the complaint sample found complying with test.Lot number of drain unknown.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: 15547492
• MDR Text Key: 306516767
• Report Number: 2210968-2022-08238
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• 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
• Date Manufacturer Received: 11/06/2022
• 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