MAUDE Adverse Event Report: ETHICON INC. BLAKE CARDIO CONNECTOR 2:1; CATHETER, IRRIGATION

Catalog Number BCC2

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

Event Description

It was reported a patient underwent an unknown surgery on an unknown date and a cardio connector was used.When the patient returned to the ward, it was confirmed that air leakage occurred.A nurse checked the product and the air leakage was coming from the cardio connector, and replacing the cardio connector fixed the air leakage.There were no adverse consequences to the patient.Additional information has been requested.

Manufacturer Narrative

Product complaint # pc(b)(4)-001529003 additional information: h6 component code: g07002 - device not returned.Additional information has been requested however not 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? please perform and document the follow up attempt for product return.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 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 complaint sample of connector was received for evaluation, having cut drain with cable tied at all three connector edges.Product was checked visually (both, with tied cable tie and without cable tie) and functionally (video attached), no negative observation or no non-compliance was noted.Complaint sample review : one complaint sample of connector was received for evaluation, having cut drain with cable tied at all three connector edges.Product was checked visually (both, with tied cable tie and without cable tie) and functionally (video attached), no negative observation or no non-compliance was noted.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.It is suspected that, external factors like mishandling or improper usage at user end could not be ruled out.As per standard practice, 100% functional test was performed on the product.Also, 100% visual inspection was carried out visually before and after packing of finished goods, prior to the product release.There was no scope to miss such defect, at manufacturing / release stage.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 CARDIO CONNECTOR 2:1
• 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 ; 9083863534
• MDR Report Key: 18699708
• MDR Text Key: 336061458
• Report Number: 2210968-2024-01335
• 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
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BCC2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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