MAUDE Adverse Event Report: ETHICON INC. BLAKE (R) DRAIN 10FR ROUND; CATHETER, IRRIGATION

Model Number 2227

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Additional information has been requested and obtained.Attempts to obtain the device however not received.If further details are received at a later date a supplemental medwatch will be sent.When the drain was found the damaged (in the package, during removal from package, during handling or during use on the patient)? please specify =during use.If it was found during use on the patient, was leakage detected? =no further information is available.Was the new drain placed surgically during a second procedure? =no further information is available.Device return status: =we regularly contact with sales rep about the device returning.No further information will be provided.

Event Description

It was reported a patient underwent an unknown surgery on (b)(6) 2021 and a drain was used.During surgery, there was damage on the drain, and there may be a hole on it.Further details are not provided.There were no adverse consequences to the patient.

Manufacturer Narrative

Product complaint #: (b)(4).Additional information: d9, h6 component code: g07002 product not confirmed.H3 evaluation: product returned for analysis.One used sample of damaged drain was received for evaluation.On inspection of drain sample, slit cut found on the drain which seems to be done with sharp object.Dmd is performing 100 % visual inspection before release of product.Defect cannot be generated during our manufacturing process.Retain samples were checked for lot and no defect related to complaint was observed.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 (R) DRAIN 10FR ROUND
• 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
• MDR Report Key: 13403324
• MDR Text Key: 285224336
• Report Number: 2210968-2022-00754
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003552
• UDI-Public: 10705031003552
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/29/2022

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
• Device Model Number: 2227
• Device Catalogue Number: 2227
• Device Lot Number: J2031274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/11/2022
• Initial Date FDA Received: 01/31/2022
• Supplement Dates Manufacturer Received: 04/22/2022
• Supplement Dates FDA Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1