MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. SAFEDAY; SET, ADMINISTRATION, INTRA

Model Number	352894
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample and/or lot number was provided for further evaluation.Without the actual device and/or lot number, a thorough investigation could not be performed.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.
Event or Problem Description
As reported by the user facility: the nurse is experiencing air in line alarms on the vista pump when administering ivig in glass bottle via tubing 352894.This does not happen with fluids in soft iv containers.The solution is not cold when administered.The tubing is vented.She sometimes sees small bubbles.She gets alarms when this occurs and she resolves by opening the door and clearing the tubing of the bubbles.No injury reported.

• Brand Name: SAFEDAY
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 11526987
• Report Number: 2523676-2021-00066
• Device Sequence Number: 5170045
• Product Code: FPA
• UDI-Device Identifier: 04046964181894
• UDI-Public: 04046964181894
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K955585
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/19/2021

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: Health Professional
• Device Model Number: 352894
• Device Catalogue Number: 352894
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 03/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1