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

Model Number	8881540111
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported they found 3 blunt tip cannulas with mold inside.
Additional Manufacturer Narrative
Additional information d 4: added lot number.The device history record (dhr) for the reported lot indicates that no issues were found in visual and physical samples inspected from the lot.A non conformance for inclusions was generated for the plastic components used for the device.A review of corrective and preventative maintenance records and calibration records were reviewed and there were no issues.There were no samples returned with this complaint however a picture that was submitted by the customer exhibited dark spots on the smarttip cannula.The failure was confirmed.Based on the review of the dhrs and the corresponding picture, the failure identified as mold is in fact inclusions of burnt acrylic plastic embedded into the cannula due to extended heating of the product during the molding process.A review of the molding process did not find any deviation within the temperature reaching outside of validated parameter.The most likely root cause was prolonged downtime where the material was subjected to this heat causing the inclusions.The brown discoloration also found in the cannula supports this as this browning affect is the first stage of temperature impact.As this issue was identified in the assembly process the most likely failure was due to incomplete containment of the defective product.The investigation did not identify a systemic issue with the product or process and no trend exists for the failure mode.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: 9202140
• Report Number: 1017768-2019-00697
• Device Sequence Number: 10874380
• Product Code: GEA
• UDI-Device Identifier: 30884521102754
• UDI-Public: 30884521102754
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 02/03/2020

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: 8881540111
• Device Catalogue Number: 8881540111
• Device Lot Number: 923832
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 02/03/2020
• Patient Sequence Number: 1