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 Consequences Or Impact To Patient (2199)
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 needle shoots fluid out at the side of the needle when under pressure at 90 degrees near the needle's base.
Additional Manufacturer Narrative
A review of the device history record (dhr) found no manufacturing or inspection anomalies indicative of syringe issue.There were no samples returned with this complaint therefore the reported condition was not confirmed.The condition was most likely caused by a flow obstruction as the place breach exhibited this visual characteristic and was identified at the thinnest part of the hub.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, the lot met all defined acceptance requirements and was released.The investigation did not identify a systemic issue with the product or process, and no trend exists for the reported condition.Therefore, a corrective and preventive action (capa) is not necessary at this time.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: 9151042
• Report Number: 1017768-2019-00694
• Device Sequence Number: 2563576
• 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,other,use
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8881540111
• Device Catalogue Number: 8881540111
• Device Lot Number: 914855
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/27/2019
• Supplement Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 05/11/2020
• Patient Sequence Number: 1