MAUDE Adverse Event Report: BD Q-SYTE VIAL ACCESS ADAPTER; INTRAVASCULAR ADMINISTRATION SET

Model Number	385108
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	09/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used as a default fda notified?: the initial reporter also notified the fda on (date) via medwatch # mw5104047.Investigation summary: since no photos or samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.Examination of the product involved may provide clarification as to the cause for the reported failure.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that bd q-syte vial access adapter leaked.The following information was provided by the initial reporter: "patient said that the last time she received vial adapter q-style from our pharmacy the adapters leaked every time she inserted them into the veletri vial and would tum the vial upside down to draw the medication out of the vial.".

• Brand Name: BD Q-SYTE VIAL ACCESS ADAPTER
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12720901
• Report Number: 9610847-2021-00524
• Device Sequence Number: 1364089
• Product Code: FPA
• UDI-Device Identifier: 30382903851080
• UDI-Public: 30382903851080
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K013621
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• 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: Other
• Device Expiration Date: 02/28/2026
• Device Model Number: 385108
• Device Catalogue Number: 385108
• Device Lot Number: 1053411
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 10/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2021
• 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