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

Model Number	BCC2
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).To date the device has not been returned.If further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported a patient underwent an unknown surgery on (b)(6) 2020 and topical skin adhesive was used.Before opening the sterile package, it was found that there had been a foreign substance like a hair in the sterile package.The product was not used and another package was opened.No sample will be returned.Further details are not provided.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Date sent to fda: 12/30/2020.Additional information: d9.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.H3 evaluation: received one unit of bcc2.The pouch is opened.There is piece of hair inside the package / inside the pouch.The complaint was observed.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 7/15/2020 corrected information: b5 it was reported a patient underwent an unknown surgery on (b)(6) 2020 and drain cardio connector was used.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.
Additional Manufacturer Narrative
(b)(4).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 2:1
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10213435
• Report Number: 2210968-2020-04970
• Device Sequence Number: 19628742
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/24/2020

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: 09/03/2024
• Device Model Number: BCC2
• Device Catalogue Number: BCC2
• Device Lot Number: J1920069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2020
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 06/24/2020; 08/17/2020; 12/21/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 07/15/2020; 09/14/2020; 12/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1