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

Model Number	CONNECTOR
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The was no patient involvement.Livanova usa inc manufactures the connector.The incident occurred in (b)(6) united states of america.The involved device has been requested for return to sorin group italia for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not yet received.
Event or Problem Description
Livanova usa inc received a report that a 1/4 x 3/8 connector used to attach tubing in the circuit was completely occluded.The was no patient involvement.
Additional Manufacturer Narrative
Livanova received a report that a 3/8 x ¼ reducer was completely occluded.The issue was identified prior to any patient involvement.The dhr review confirmed the lot of the reduces was released conforming to product specifications.Analysis of the livanova complaint database of the last 12 months identified two previous similar events related to the same catalogue item code.Investigation results suggested the reduced was occluded by a plastic film likely due to a molding defect.Thus, suggesting a manufacturing issue.The reducer is manufactured by a livanova supplier that has been formally notified of the issue.Due to other manufacturing needs, the catalogue item code of the complained 3/8 x ¼ reducer was already planned to be substituted by another similar reducer.To prevent re-occurrence, livanova anticipate the change and will discard all the inventory of the complained reducer.At the moment, no other action is deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.

• Brand Name: 1/4 X 3/8 CONNECTOR
• Common Device Name: 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: 12714555
• Report Number: 1718850-2021-00049
• Device Sequence Number: 14590223
• Product Code: DTL
• UDI-Device Identifier: 00803622129315
• UDI-Public: (01)00803622129315(240)EC2140S(17)231031(10)2030100015
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXPEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2021

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: 10/31/2023
• Device Model Number: CONNECTOR
• Device Catalogue Number: EC2140S
• Device Lot Number: 2030100015
• 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: 09/30/2021
• Supplement Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2020
• 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