MAUDE Adverse Event Report: ETHICON INC. BLAKE SI DRAIN HBLS 10FR RND W/ 1/8IN; CATHETER, IRRIGATION

Catalog Number 2227

Device Problem Leak/Splash (1354)

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

Event Date 12/07/2023

Event Type  malfunction  

Event Description

It was reported a patient underwent an unknown surgery on (b)(6) 2023 and a drain was used.A nurse realized that the bed was soiled with leaking drainage fluid.The nurse suspected a faulty connection between the reservoir and drain and changed the reservoir, but when the situation did not change, the nurse checked the drain and found that some part of the tube was leaking waste fluid outside the body.There were no adverse consequences to the patient.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned.Additional information provided: there were no sharp objects in the ward.The nurse said, " there were no sharp objects where the drain tube was placed during surgery.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? unk.Please perform and document the follow up attempt for product return.We regularly contact with sales rep about the device returning.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.

Manufacturer Narrative

Product complaint # (b)(4).H3 evaluation: one used drain sample was received for evaluation.Product was inspected visually, below are detailed findings: there were few black traces inside the drain.A tiny hole was visible on the drain.The hole was inspected under zoomed condition then found that there was a deep cut at the drain surface.As per standard practice, 100 % functional test and 100% visual inspection was carried out, visually.Before and after packing of finished goods, prior to the product release.No scope to miss such claimed defect, at manufacturing / release stage.Documents review : batch manufacturing record review is not performed, as the lot no of complaint is unknown.Retention sample review : retention sample is not checked, as the lot no of complaint 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.

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 issue with the reservoirs/2? no.Please address with the customer if there is no issue, is an evaluation needed? no.It was returned because it was used with the drain that had the issue.So an evaluation is not needed.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 HBLS 10FR RND W/ 1/8IN
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): DEGANIA SILICON LTD.-INDIA; 251, sector-6, imt manesar; gurugram ; IN
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18460102
• MDR Text Key: 332285122
• Report Number: 2210968-2024-00175
• Device Sequence Number: 1
• Product Code: GBX
• 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,Followup
• Report Date: 03/07/2024

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 Catalogue Number: 2227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 01/05/2024
• Supplement Dates Manufacturer Received: 02/07/2024; 03/02/2024
• Supplement Dates FDA Received: 02/27/2024; 03/07/2024
• 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