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

Model Number 8881540111

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2019

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 registered nurse attached needleless cannula to syringe, drew up air, inserted needleless cannula into zofran vial, and pushed in air.The medication shot out of the side of the needleless cannula and the dosage was wasted.The registered nurse tested another needless cannula from the same lot number and leaking was noticed again.No patient harm reported.

Manufacturer Narrative

H 3 evaluation summary: the device history record (dhr) for the reported lot shows no issues were found in visual and physical samples inspected.There were no non-conformance reports (ncr) issued against the lot.There were 7 (unopened, unused) and 2 (opened, used) smartip needles returned for evaluation.The samples were visually inspected under magnification and two of the needles had one small hole on the side of the smartip cannula, close to the ribs of the smartip.All samples were physically tested for leakage and all passed except the two needles with the holes.The reported condition is confirmed.A possible root cause could be embedded inclusions residing within the smartip cannula.Inclusions are caused by material exposed to excessive heat for prolonged time causing black specs to propagate.These black specs are hard and can impede material flow in the injection molding process leading to micro fractures.Per the sample analysis, two of the needles were identified with little holes / micro fractures on the smartip cannula.Based on the information available, this could be the most likely root cause of the failure.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
• Type of Device: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 9402859
• MDR Text Key: 173074526
• Report Number: 1017768-2019-00745
• 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: other
• 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: 12/03/2019
• 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: 919701
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/25/2019
• Patient Sequence Number: 1