MAUDE Adverse Event Report: MEDSAFETY SOLUTIONS KWIKVIAL CONTAINER 15ML; LIQUID MEDICATION DISPENSER

Model Number	30015
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a foreign object was found in a kwikvial container.The issue was identified before use.No patient involvement.
Additional Manufacturer Narrative
Complaint received from pharmacy supervisor that a screw was found in a sealed kwikvial container.The foreign object was detected prior to administration.No patient involvement.The customer has been requested to forward the device for evaluation.Preliminary investigation suggests that the screw was from manufacturing equipment used to process the containers.Batch record review was conducted; no deviations or non-conformances related to this type of incident were described.No other complaints related to this type of incident have been reported.

• Brand Name: KWIKVIAL CONTAINER 15ML
• Common Device Name: LIQUID MEDICATION DISPENSER
• Manufacturer (Section D): MEDSAFETY SOLUTIONS; 7012 s revere pkwy, suite 120; centennial CO 80112
• Manufacturer Contact: rich weiskopf ; 7012 s. revere pkwy; suite #120; centennial, CO 80112 ; 7205002500
• MDR Report Key: 14211346
• Report Number: 3013445787-2022-00001
• Device Sequence Number: 17533425
• Product Code: KYX
• UDI-Device Identifier: 00853832007019
• UDI-Public: (01)00853832007019(10)XXXXXX
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 04/06/2022

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: Health Professional
• Device Model Number: 30015
• Device Catalogue Number: 30015
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown