MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL MODIFIED STOCKERT-SHILEY VENOUS CATHETER; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Catalog Number	V132-10
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information were not provided.Sorin group (b)(4) manufactures the v132-10 - venous return cannulae fr10.The incident occurred in (b)(6), united states of america.Follow up communication with the customer confirmed all 40 units received by the customer were indeed fr10 cannula with fr12 printed on the cannula.The customer has disposed 5 units and has returned to sorin group (b)(4) (belonging to livanova group) all the 35 remaining units.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Dimensional analysis of the returned units confirmed the french of the devices was conforming to product specification and was the same as per indication in the pouch (10 fr).The blue print was incorrect.Livanova consider the issue ascribable to a human error.All 40 units have been sent to a single customer.No other affected unit has been distributed on the usa market.All the remaining units have been returned to livanova as a part of the investigation.As all units have been returned, no other action on the market is deemed necessary.
Event or Problem Description
Livanova usa inc has been informed that, during a cannulation, the v132-10 - venous return cannulae fr10, had the 12fr blue printing on the cannula instead of the 10fr blue printing.There is no report of any patient injury.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
Livanova received a report regarding incorrect labelling of v132-10 cannulae: units were french 10, labelled in the pouch as french 10 and contrary blue-print labelled on the body of the cannula was french 12.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The customer has disposed 5 units and has returned to livanova all the 35 remaining units for investigation.Dimensional analysis of the returned units confirmed that the french of the devices was conforming to product specification and was the same as per indication in the pouch (10 fr).The blue print was incorrect.Based on the above facts, the root cause of the reported event was manufacturing operator failure during printing phase addressed by ncr-mir-2021-0140.A short-term containment action has been issued by adding an additional check of the presence and conformity of the logo and markers in local procedure (b)(4).All (b)(4) units have been sent to a single customer.No other affected unit has been distributed on the usa market.All the remaining units have been returned to livanova as a part of the investigation.As all units have been returned, no other action on the market is deemed necessary.No other specific action was currently deemed necessary, livanova maintains monitoring the market.

• Brand Name: MODIFIED STOCKERT-SHILEY VENOUS CATHETER
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola, modena
• MDR Report Key: 11885013
• Report Number: 9680841-2021-00014
• Device Sequence Number: 19683155
• Product Code: DWF
• UDI-Device Identifier: 38033178004528
• UDI-Public: (01)38033178004528(17)230707(10)2007070021(11)200707(240)V132-10
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K890980
• 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
• Report Date (Section B): 07/28/2021

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: 07/07/2023
• Device Catalogue Number: V132-10
• Device Lot Number: 2007070021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1