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

Model Number 2227

Device Problems Break (1069); Use of Device Problem (1670)

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

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Additional information has been requested and received.If further details are received at a later date a supplemental medwatch will be sent.Were there any anomalies with the drain: appearance, damage, or function prior to use? no further information is available.Was the trocar needle broke into two or more pieces? no further information is available.Was another drain needed to correct the situation? no further information is available.If yes, was the new drain placed surgically during the same procedure? no further information is available.How was the cut on the surgeon's hand treated? no further information is available.What is the lot number? no further information is available.Device return status: we regularly contact with sales rep about the device returning.No further information will be provided.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 orthopedic surgery on an unknown date and a drain was used.During surgery, the trocar needle was broken.The surgeon commented that he used the standard trocar needle while bending it a lot.He cut his hand a little bit, but there was no problem.Further details are not provided.There were no adverse consequences to the patient and no reported consequences to physician.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).H3 evaluation: product sample received.One used sample of trocar received for evaluation (in 2 broken pieces).On visual inspection of received sample trocar found bent.Lot number of product is unknown.This product code is 10 fr round, hubless blake¿ silicone drain with trocar 1/8".This trocar is non bendable trocar.As per the complaint statement " the surgeon commented that he used the standard trocar needle while bending it a lot.He cut his hand a little bit, but there was no problem." application of trocar by the user may be improper as this trocar is non-bendable.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: 13400116
• MDR Text Key: 291285565
• Report Number: 2210968-2022-00744
• 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: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1