MAUDE Adverse Event Report: COVIDIEN MAGELLAN SAFETY COMBO; SAFETY NEEDLE AND SYRINGE

Model Number 8881833510

Device Problem Device Operates Differently Than Expected (2913)

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 states that it appears that when the item was molded, the plastic remained on the plunger portion of the syringe.

Manufacturer Narrative

Submit date: (b)(6) 2016.A device history record review of the reported lot number(s) confirmed that the product was produced accomplishing quality requirements and released according to established procedures.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.A review of the machine in its current condition was conducted by the quality engineer and there were no issues.There was one (1) sample (opened) returned with this complaint.The quality engineer performed a visual examination to the sample returned.Inside the barrel a black piece of rubber plunger tip was found.The size of the piece was big enough to be noticed by the user.The reported condition is confirmed.Based on the investigation it was determined that the unidentified matter was a piece of plastic from the rubber plunger tip.The definitive root cause of the issues could not be determined, however, the most likely root cause could be that during the process of the syringe assembly the rubber plunger tip got stock somewhere getting damaged and subsequently got transferred to the barrel.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.Based on trends, no corrective / preventive actions will be taken 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: MAGELLAN SAFETY COMBO
• Type of Device: SAFETY NEEDLE AND SYRINGE
• 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: 5264436
• MDR Text Key: 32807548
• Report Number: 1017768-2015-00035
• Device Sequence Number: 1
• Product Code: BSP
• 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,Followup
• Report Date: 11/20/2015

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: Other
• Device Model Number: 8881833510
• Device Catalogue Number: 8881833510
• Device Lot Number: 523041X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/20/2015
• Initial Date FDA Received: 12/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1