MAUDE Adverse Event Report: ETHICON INC. BLAKE SI DRAIN 10MM FLAT 3/4 FLUTED W/ 3/16IN TR; CATHETER, IRRIGATION

Model Number 2217

Device Problem Leak/Splash (1354)

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

Event Date 09/26/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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.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." in this event, drain breakage did not occur, only crack formation.After removal of the drain, the drain was not reinserted, and the patient was followed up.No reoperation, or re-opening the wound has been performed.After that, there is no problem with the patient¿s condition.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.

Event Description

It was reported a patient underwent a breast surgery on (b)(6) 2022 and a drain was used.The product was used.Immediately after the surgery, in the ward, it was confirmed that air leaked from the product, and when it was removed from the body, it was found that it was ruptured.The product was used on subcutaneous.Further details are not provided.There were no adverse consequences to the patient.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).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.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." in this event, drain breakage did not occur, only crack formation.After removal of the drain, the drain was not reinserted, and the patient was followed up.No reoperation, or re-opening the wound has been performed.After that, there is no problem with the patient¿s condition.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.

Event Description

It was reported a patient underwent a breast surgery on (b)(6) 2022 and a drain was used.The product was used.Immediately after the surgery, in the ward, it was confirmed that air leaked from the product, and when it was removed from the body, it was found that it was ruptured.The product was used on subcutaneous.Further details are not provided.There were no adverse consequences to the patient.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Additional information: d9 h3 evaluation: one used sample of drain is received in two parts.During visual inspection of both the parts separately, we have not found any air hole or rupture marks.As per standard process, 100% inspection carried out before packing of finished goods and a after packing,before release.Ii ls suspected that leakage i rupture might likely to happen with some sharp tool used during the surgery.External factors like improper handling.And improper usage at user end could not be ruled out.Retain sample analysis could not be performed as the lot no.Is 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 SI DRAIN 10MM FLAT 3/4 FLUTED W/ 3/16IN TR
• 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: 15611402
• MDR Text Key: 306841700
• Report Number: 2210968-2022-08455
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003538
• UDI-Public: 10705031003538
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2217
• Device Catalogue Number: 2217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2022
• 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