MAUDE Adverse Event Report: LIVANOVA USA INC 1/4 X 3/8 REDUCING CONNECTOR; CONNECTORS

Model Number CONNECTOR

Device Problem Material Deformation (2976)

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

Event Type  malfunction  

Manufacturer Narrative

Patient id, age or dob, sex, weight, ethnicity: the was no patient involvement.Event date is unknown.Livanova usa inc manufactures the connector.The incident occurred in (b)(6).The involved device has been received at livanova arvada.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova usa inc received a report that catalogue item # ec2140s 1/4x3/8 reducing connector is occluded and cannot flow through it during priming.In total of 3 units are affected however only 1 unit will be returned.The was no patient involvement.

Manufacturer Narrative

Livanova received a report of a occluded connector.The complained connector was returned to livanova for investigation.Visual inspection revealed that the reducer was occluded near the base of the 1/4 "end.Moreover, the material that occluded the reducer was the same as the component itself.The dhr review highlighted that the lot whose claimed product belong to was released as conform according to specifications.Review of the livanova complaint database identified other three similar events in the last year.Based on above, livanova believes the occlusion was caused by a molding defect likely due to a defective supplied component.The supplier of the component was formally informed of the issue.Inventory still present in livanova has been disposed and a new item code has been created in livanova.The risk is in the acceptable region.No other action is deemed necessary.Livanova will keep monitoring the market.

Event Description

See intial report.

• Brand Name: 1/4 X 3/8 REDUCING CONNECTOR
• Type of Device: CONNECTORS
• Manufacturer (Section D): LIVANOVA USA INC; 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: 14453117
• MDR Text Key: 293346363
• Report Number: 1718850-2022-00038
• Device Sequence Number: 1
• Product Code: DTL
• UDI-Device Identifier: 00803622129315
• UDI-Public: (01)00803622129315(240)EC2140S(17)230831(10)2023800120
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: CONNECTOR
• Device Catalogue Number: EC2140S
• Device Lot Number: 2023800120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2020
• 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