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

Catalog Number AR-11114

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/16/2023

Event Type  malfunction  

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 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 Description

See initial report.

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.

• Brand Name: ANTEGRADE CARDIOPLEGIA NEEDLE 14FR
• Type of Device: 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
• MDR Text Key: 328503809
• Report Number: 1718850-2023-00036
• Device Sequence Number: 1
• Product Code: DWZ
• UDI-Device Identifier: 00803622103056
• UDI-Public: (01)00803622103056(240)AR-11114(17)260306(10)2306600076
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/13/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/07/2023
• 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