MAUDE Adverse Event Report: COVIDIEN NDL CE SMARTIP CANN SOFTPACK; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	8881540111
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported that they have experienced issues with this product leaking out of the side of the cannula when pulling medication out of a vial and spraying out towards the clinician.Additionally, the caps have also been reported to fall off very easily.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed and did not find any incident related to the reported condition.Visual and physical inspections were performed in process and no issues were identified in production.No physical sample was returned for evaluation.The reported issue could not be confirmed.The root cause of the reported problem could not be determined.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.Although this failure could not be confirmed, a corrective and preventative action (capa) was opened regarding leaking smart tip assembly based on a previously confirmed complaint.The capa is currently in the implementation phase.This information will be utilized for trending purposes to determine the need for additional corrective actions.This complaint will be used for tracking and trending purposes.

• Brand Name: NDL CE SMARTIP CANN SOFTPACK
• Common Device Name: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 12358812
• Report Number: 1017768-2021-00976
• Device Sequence Number: 14406016
• Product Code: GEA
• UDI-Device Identifier: 30884521102754
• UDI-Public: 30884521102754
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 10/07/2021

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: 110422
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 10/07/2021
• Patient Sequence Number: 1