MAUDE Adverse Event Report: CFN MEXICO 215 SA DE CV DEHPFREE PRI GRAV SET 1 SS VLV; INTRAVASCULAR ADMINISTRATION SET

Model Number	41173E
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	06/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: no product or photo was returned by the customer.The customer complaint of air in the line could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 41173e because a lot number was not provided by the customer.Root cause analysis: due to no sample being received, an investigation could not be performed and a root cause could not be determined.Investigation conclusion: this incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that dehpfree pri grav set 1 ss vlv had air in the line.The following information was provided by the initial reporter: material no.: 41173e.Batch no.: unknown.It was reported that two events involving bd smartsite gravity set occurred.(b)(4).(b)(6) 2020 @ 1430.((b)(6) of age).Gravity set in use in ed setting with fluids running and another medication given through port.Pt went to ct and air embolism was noted in heart.A very similar event occurred a few weeks earlier in same setting.This pt was subsequently discharge.We don¿t know for a fact that there is an issue but are concerned with 2 very similar events in a short amount of time.Customer response 30-jun-2020: 2 events, 1 pt expired, 1 pt was safely discharged.We do not have the original product to return.

• Brand Name: DEHPFREE PRI GRAV SET 1 SS VLV
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): CFN MEXICO 215 SA DE CV; parque industrial el florido.; tijuana, null 22244 ; MX 22244
• MDR Report Key: 10316699
• Report Number: 9616066-2020-02194
• Device Sequence Number: 2525771
• Product Code: FPA
• UDI-Device Identifier: 07613203020893
• UDI-Public: 7613203020893
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K820278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 41173E
• Device Catalogue Number: 41173E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR