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

Model Number	BCC1
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
Event or Problem Description
It was reported a patient underwent an unknown surgery on an unknown date and a cardiac drain connector was used.During procedure, red fibrous foreign matter was found in the sterile package, it was not used.Further details are not provided.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Product complaint #(b)(4); evaluation: one sealed pouch as complaint sample was received for evaluation, during visual inspection, red fibrous foreign matter in sterile package was observed.One sealed pouch as complaint sample was received for evaluation, during visual inspection, tiny red fibrous foreign matter in sterile package was observed.Retention sample of complaint lot were checked and found satisfactory.Earlier, capa, was already taken, and detailed investigation was shared.Corrective action was taken, as hair / fibre was received in tyvek pouch from supplier, and the actions were requested from supplier, these actions are under progress at manufactrurers end.During investigation of the complaint, bmr and retained sample review was performed.No discrepancy as per the reported defect was observed.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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 1:1
• Common Device Name: 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: 17034605
• Report Number: 2210968-2023-03971
• Device Sequence Number: 6516194
• Product Code: GBX
• UDI-Device Identifier: 10705031023314
• UDI-Public: 10705031023314
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/31/2023

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 Model Number: BCC1
• Device Catalogue Number: BCC1
• Device Lot Number: J2141356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown