MAUDE Adverse Event Report: ETHICON INC. 24 FR RD BLAKE HBLS SILC; CATHETER, IRRIGATION

Model Number 2234

Device Problem Leak/Splash (1354)

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

Event Date 11/15/2021

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.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.Additional information received: air leak also occurred with the new drain, but after the black spot mark part was implanted into the chest cavity, the leak resolved, so the surgery was completed (per ifu).It was commented that since the patient was good build, the grooves of the drain might have been coming out of the body surface.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.

Event Description

It was reported a patient underwent an esophageal surgery on (b)(6) 2021 and a drain was used.During surgery an air leak occurred.On (b)(6), after completion of chest operation, the device was placed in the chest cavity.When the drain was fixed to the skin at the black spot mark, air leak occurred.So, another 24 fr drain was used.It was commented that since the patient was good build, the grooves of the drain might have been coming out of the body surface.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 reported condition not confirmed.H3 evaluation: product received for analysis.Retain sample of the same lot was checked and found within the specified criteria.One used sample of drain was received for analysis.Drain sample was checked visually and no discrepancy found in it.As per the complaint, concludes that leak was resolved after the drain channel was inserted properly.Drain sample is found satisfactory after visual inspection.During the surgery, it is unknown whether the complete channel was inserted into the chest cavity.Improper placement of drain may affect the performance of the device.Care must be taken to ensure that all drain channels lie completely within the wound or cavity to be drained.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: 24 FR RD BLAKE HBLS SILC
• 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: 12961074
• MDR Text Key: 286867325
• Report Number: 2210968-2021-12430
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003620
• UDI-Public: 10705031003620
• 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: 01/24/2022

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: 2234
• Device Catalogue Number: 2234
• Device Lot Number: J2030381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2021
• Initial Date FDA Received: 12/08/2021
• Supplement Dates Manufacturer Received: 12/27/2021
• Supplement Dates FDA Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1