MAUDE Adverse Event Report: ETHICON INC. BLAKE (R) DRAIN 15FR R/F; CATHETER, IRRIGATION

Model Number 2229

Device Problem Leak/Splash (1354)

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

Event Date 11/29/2021

Event Type  malfunction  

Event Description

It was reported a patient underwent an unknown cardiovascular surgery on (b)(6) 2021 and drain was used.Immediately after the patient entered the picu, an air leak occurred.When it was removed and checked, a crack was found.The method of use was the same as usual.Further details are not provided.There were no adverse consequences to the patient.

Manufacturer Narrative

Product complaint # (b)(4).Lot #: 4 possible lot numbers were provided: j2020534, j2104731, j2109033, j2104732.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.Please confirm, were 4 lot numbers provided as it is unknown which of these 4 lots was the correct one (j2020534, j2104731, j2109033, j2104732)? or were 4 products involved in the event? qty of product involved is 1.These 4 lots are possible lot numbers.No further information is available.Can you please identify/clarify which is the correct lot number? 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 a second procedure? did the drain come in contact with surgical instruments, surgical needles, sutures, sharp objects at any time? no further information is available.Device return status? we regularly contact with sales rep about the device returning.No further information will be provided.

Manufacturer Narrative

Product complaint # (b)(4).H3 evaluation: product received for analysis.Retain sample of the same lot no.J2020534, j2104731, j2109033, j2104732 was checked and found within the specified criteria.Sample evaluation for air leak could not be performed with small piece of drain sample received.100% inspection performed for finished goods before release.The crack mark on drain might likely happen with some sharp tool used during the operation process.The device history records were reviewed and the manufacturing criteria was met prior to the release of the 4 possible lots: product lot # j2020534 manufacturing.Date jul 16, 2020 expiration date jul 31, 2025.Product lot # j2104731 manufacturing.Date jan 25, 2021 expiration date jan 31, 2026.Product lot # j2104732 manufacturing.Date jan 28, 2021 expiration date jan 31, 2026.Product lot # j2109033 manufacturing.Date mar 12, 2021 expiration date mar 31, 2026.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 15FR R/F
• 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 12205 2; IN 122052
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13097573
• MDR Text Key: 286057955
• Report Number: 2210968-2021-13026
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003576
• UDI-Public: 10705031003576
• 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: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2229
• Device Catalogue Number: 2229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1