MAUDE Adverse Event Report: LIVANOVA US ANTEGRADE CARDIOPLEGIA NEEDLE 14FR; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Catalog Number	AR-11114
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.10.Livanova manufactures the antegrade cardioplegia needle 14fr.The incident occurred in (b)(6).The involved device has been requested for return to livanova us for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova usa inc.Has been informed that, during procedure, luer cap at the end of the needle fell off.There was no patient injury.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H10: through follow-up communication livanova learned that the affected part is the white plastic one near the tip and not the luer cap at the end of the needle, as erroneously reported in the previous report (mfr#1718850-2023-00036).Moreover, it was learned that the affected unit was discarded by the customer.No photos were provided.By reviewing the complaints database no further similar event was recorded on this product code.The involved cannula tip is assembled to the y connector through the use of uv adhesive 191-m during manufacturing.Based on the available information, it cannot be excluded that an isolated operator error occurred during the assembly phase of this product due to insufficient adhesive application.To prevent re-occurrence, the manufacturing personnel has been involved in a dedicated training meeting to discuss the specific event.H3 other text : device discared by customer.
Additional Manufacturer Narrative
**udi related data quality updates only** d2.Correct device product code updated in the dedicated section d2b.
Event or Problem Description
See initial report.

• Brand Name: ANTEGRADE CARDIOPLEGIA NEEDLE 14FR
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA US; 14401 w 65th way; arvada CO 80004
• Manufacturer (Section G): LIVANOVA USA INC.; 14401 w 65th way; arvada CO 80004
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 18139449
• Report Number: 1718850-2023-00036
• Device Sequence Number: 6467167
• Product Code: DWF
• UDI-Device Identifier: 00803622103056
• UDI-Public: (01)00803622103056(240)AR-11114(17)260306(10)2306600076
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K972503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/02/2024
• 2 Devices were Involved in the Event: 1 2

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: 03/06/2026
• Device Catalogue Number: AR-11114
• Device Lot Number: 2306600076
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2023
• Supplement Date Received by Manufacturer: 12/28/2023; 08/02/2024
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 01/25/2024; 08/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2023
• 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