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

Model Number 8881540111

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2019

Event Type  malfunction  

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 Description

The customer reported that the certified registered nurse anesthetist noted visible black particles in the monojet needleless blunt cannula.This was noted when the medication was drawn up, which was not given to the patient.

Manufacturer Narrative

Additional information: the device history record (dhr) for the reported lot indicates no issues were found in visual and physical samples inspected.Needle shop order numbers were reviewed and found that a non-conformance report (ncr) for inclusions was generated in the plastic components used.All scheduled maintenance and calibration activities were completed.There were no samples returned with this complaint, however a picture was provided showing the issue and the reported condition was confirmed.Based on the review of the dhr and evaluation of the picture provided, the failure identified is most likely inclusions of burnt acrylic plastic embedded in the cannula.This is 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.As this issue was identified in the assembly process the most likely failure was due to incomplete containment of the nonconforming product.The investigation did not identify a systemic issue with the product or process, no trend exists for the failure mode.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
• Type of Device: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 9298011
• MDR Text Key: 166322247
• Report Number: 1017768-2019-00729
• Device Sequence Number: 1
• Product Code: GEA
• UDI-Device Identifier: 30884521102754
• UDI-Public: 30884521102754
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8881540111
• Device Catalogue Number: 8881540111
• Device Lot Number: 923832
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/16/2019
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 87