MAUDE Adverse Event Report: SORIN GROUP USA, INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS; SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS

Catalog Number	SU-12202
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The involved device is not available for return to sorin group usa.However, inventory of this product was identified and is available for return.If any additional information relevant to the reported event is received, it will be submitted in a supplemental report.
Event or Problem Description
Sorin group received a report that the suction nozzle of the rigid tip suction wand disconnected from the handle while suctioning the pleural fluid during a procedure and fell inside the patient's chest cavity.The tip was recovered quickly and removed from the patient with no injury.
Additional Manufacturer Narrative
In the initial report, submitted on july 19, 2017, it was stated that inventory of this product was identified and is available for return.However, this was incorrect.During follow-up communication with the distributor on july 10, 2017, sorin group learned that the inventory originally thought to be available for return was no longer available, as it had already been distributed to customers.However, research found that this lot number was built for a total quantity of 802 units and that in the past year over 23,000 rigid tip suction wands have been manufactured and shipped.This is the first and only report for tip disconnection of the suction wand product that has been received by sorin group.As the device was not saved for return, no photos were taken and no inventory was available, a detailed investigation could not be performed and a root cause was not determined.Sorin group will continue to monitor for trends related to this type of issue.

• Brand Name: STANDARD AND SMALL RIGID TIP SUCTION WANDS
• Common Device Name: SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP USA, INC.; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 6726431
• Report Number: 1718850-2017-00012
• Device Sequence Number: 19038075
• Product Code: DTS
• UDI-Device Identifier: 10803622105811
• UDI-Public: (01)10803622105811(240)SU-12202(17)2020331(10)1706500150
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K982891
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2017

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: 03/31/2020
• Device Catalogue Number: SU-12202
• Device Lot Number: 1706500150
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/29/2017
• Supplement Date Received by Manufacturer: 07/10/2017
• Initial Report FDA Received Date: 07/19/2017
• Supplement Report FDA Received Date: 08/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1