MAUDE Adverse Event Report: COVIDIEN 3ML SMARTIP MED-PREP CANNULA; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	8881540133
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/24/2019
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 when drawing up the medication, the medication squirts out from the holes lower on the blunt tip.Additional information received from the customer stated that when the solution in the syringe is being pushed out, there are tiny little streams that come out of the syringe other than from the tip of the cannula.There were two tiny dots noted that spew out the liquid.There was no patient involved.
Additional Manufacturer Narrative
A review of the device history record (dhr) found no manufacturing or inspection anomalies indicative of syringe issue.There was one sample returned for evaluation and the reported condition was 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: 3ML 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: 9169835
• Report Number: 1017768-2019-00696
• Device Sequence Number: 14146833
• Product Code: GEA
• UDI-Device Identifier: 10884521082946
• UDI-Public: 10884521082946
• 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): 01/27/2020

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: 8881540133
• Device Catalogue Number: 8881540133
• Device Lot Number: 912300
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 01/27/2020
• Patient Sequence Number: 1