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

Model Number	8881540111
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2021
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 the drug was squirting out of a small hole or crack of the monoject smartip needleless vial access cannula.There was no patient injury.
Additional Manufacturer Narrative
The device history record review found that there were no related issues recorded throughout the manufacturing and control processes.The product was in conformance to specifications and was released for distribution meeting all established quality assurance acceptance levels.Two samples were returned to the manufacturing site for evaluation confirming the reported issue; the leak was identified between the connection points to the sheath, commonly referred to as the ¿ears¿ of the hub.This portion of the hub is the area with the least amount of plastic thickness.Based on this evaluation it is most likely that the condition occurred within the molding process and is indicative of inclusions within the molding process that may obstruct material flow.The investigation did not identify a systemic issue or trend with the product or process therefore, a corrective and preventive action (capa) is not necessary at this time.Further analysis will be performed to track and trend any adverse results.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: 11236625
• Report Number: 1017768-2021-00900
• Device Sequence Number: 19693189
• Product Code: GEA
• UDI-Device Identifier: 30884521102754
• UDI-Public: 30884521102754
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 04/16/2021

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: 032160
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 01/27/2021
• Supplement Report FDA Received Date: 04/16/2021
• Patient Sequence Number: 1