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

Model Number 8881540133

Device Problem Particulates (1451)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with a syringe.The customer reports that, prior to use, red specs were seen inside the syringe barrel.The customer reports that when the syringe was filled with water the specs become loose particles.

Manufacturer Narrative

Submit date: (b)(6) 2016.The device history record (dhr) for lot 518313x indicates that no defects were found in (b)(4) samples inspected from the lot.A review of maintenance records (both corrective and preventive) and calibration records were reviewed and there were no issues.There were no related processes or material changes related to the reported condition for this product.A review of the machine setup was conducted and there were no issues.Observation of machine in its current condition was performed by the quality engineer.No issues were found.There were no samples submitted with this complaint.The reported condition could not be confirmed.Complaint shall be reopened if a sample is received.Based on the customer information the most likely root cause was an introduction of an unknown matter source during the procedure.No red color element was found during the manufacturing process.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 lot met all defined acceptance requirements and was released.Since the customer issue was not confirmed no corrective/preventive action could be determined at this time.This information will be utilized for trending purposes to determine the need for corrective actions.The production department will be notified of this incident with a copy of this complaint response.

• Brand Name: 3ML SMARTIP MED-PREP CANNULA
• Type of Device: VIAL ACCESS CANNULA
• Manufacturer (Section D): COVIDIEN; 2010 east international speedway blvd.; deland FL 32720
• Manufacturer (Section G): COVIDIEN; 2010 east international speedway blvd.; deland FL 32724
• Manufacturer Contact: thom mcnamara ; 15 hampshire st; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5144883
• MDR Text Key: 28480492
• Report Number: 1017768-2015-00025
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 10/12/2015

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
• Device Lot Number: 518313X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1