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

Model Number	BCC2
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information has been requested and received.If further details are received at a later date a supplemental medwatch will be sent.Device return status: we regularly contact with sales rep about the device returning.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported a patient underwent an unknown procedure on an unknown date and a cardio connector was used.It was found that there had been a foreign substance like a hair in the sterile package.Further details are not provided.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Product complaint #(b)(4).H6 component code: g07002 reported condition not confirmed.H3: evaluation: product sample received.Retain sample of lot number were checked visually and found within the specified criteria.During evaluation, one intact pack containing cardio connector was received for evaluation.On opening the pack, no foreign substance was observed.Complete sample was inspected, and no foreign matter found on the product.There was no evidence of foreign particle when retain sample was checked.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: BLAKE CARDIO CONNECTOR 2:1
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): DEGANIA SILICON LTD.-ISREAL; degania bet; emek hayarden 15130 ; IS 15130
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12357925
• Report Number: 2210968-2021-07600
• Device Sequence Number: 3794807
• Product Code: GBX
• UDI-Device Identifier: 10705031023321
• UDI-Public: 10705031023321
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: CL I EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/03/2025
• Device Model Number: BCC2
• Device Catalogue Number: BCC2
• Device Lot Number: J2023908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2021
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown