MAUDE Adverse Event Report: COVIDIEN 3ML SMARTIP MED-PREP CANNULA; NEEDLESS CANNULA

Model Number 8881540133

Device Problem Device Contamination With Biological Material (2908)

Patient Problem No Patient Involvement (2645)

Event Date 01/11/2017

Event Type  malfunction  

Manufacturer Narrative

Submit date: 2/6/2017.An investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien on 1/18/2017 that a customer had an issue with a needless cannula.The customer reported finding a hair in the syringe she used to draw medication with from a vial.The customer believes that the hair was in the syringe and was not drawn from the vial into the syringe.

• Brand Name: 3ML SMARTIP MED-PREP CANNULA
• Type of Device: NEEDLESS CANNULA
• Manufacturer (Section D): COVIDIEN; 2010 east international speedway blvd.; deland FL 32720
• Manufacturer (Section G): COVIDIEN; 2010 east international speedway blvd.; deland FL 32720
• Manufacturer Contact: edward almeida ; 15 hampshire st.; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6305604
• MDR Text Key: 66873371
• Report Number: 1017768-2017-00023
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/18/2017

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
• Device Operator: Health Professional
• Device Model Number: 8881540133
• Device Catalogue Number: 8881540133
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/18/2017
• Initial Date FDA Received: 02/06/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1