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

Model Number	8881540111
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.¿ if the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.¿ as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported that the monoject needleless med prep cannula sprayed a stream of fluid out of the side, not just the tip.There was no patient injury.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.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.The device was manufactured on march 23, 2021.One used physical sample was received for the investigation.In addition, a video was provided.The sample was functionally tested, and the video was reviewed.The reported issue was confirmed.The most likely cause was determined to be due to low volume flow of resin to create the part as the sample was leaking at the thinnest portion of the cannula wall which would be the most impacted point of the component due to volume restriction.Volume restriction could occur for multiple reasons including machine fluctuation, material variance, and flow obstruction.A review of the molding records did not yield any information that would point to any failure occurring during production.However, as part of continuous improvements, a corrective and preventative action (capa) has been initiated to review the process and defect criticality along with testing requirements.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: 12177957
• Report Number: 1017768-2021-00963
• Device Sequence Number: 1521355
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2021

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: No Information
• Device Model Number: 8881540111
• Device Catalogue Number: 8881540111
• Device Lot Number: 109009
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 10/04/2021
• Patient Sequence Number: 1