MAUDE Adverse Event Report: COVIDIEN SMARTIP MED-PREP CANNULA; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	8881540111
Medical Device Problem Codes	Fluid/Blood Leak (1250); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.¿ as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.¿ if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that when drawing up the drug fentanyl, in their gi center, the medication sprayed out of the sides of the needleless cannula at the connection where it was attached to the bd syringe.The customer is unsure if the issue was with the cannula or the syringe.The medication had to be wasted.Anecdotally, this has happened to several other nurses while drawing up their drugs also.There has been no patient harm.
Additional Manufacturer Narrative
Samples were not received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue and determine a root cause.Prior to a lot¿s release, the lot must be deemed acceptable by passing inspections that are based on a valid sampling plan.Inspectors routinely examine a statistical sample both physically and visually.Specifically, visual inspections are performed to evaluate the legitimacy of the lidding.Although the reported issue could not be confirmed based on the available information, a corrective and preventative action has been opened to further investigate leaking smart tip assemblies and is currently in the implementation phase.This information will be utilized for trending purposes to determine the need for corrective actions.

• Brand Name: SMARTIP MED-PREP CANNULA
• Common Device Name: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 12253016
• Report Number: 1017768-2021-00965
• Device Sequence Number: 3718709
• Product Code: GEA
• UDI-Device Identifier: 30884521102754
• UDI-Public: 30884521102754
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

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 Model Number: 8881540111
• Device Catalogue Number: 8881540111
• Device Lot Number: 110600
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/26/2021
• Supplement Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 07/30/2021
• Supplement Report FDA Received Date: 10/05/2021
• Patient Sequence Number: 1