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

Model Number	V1482
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
Event or Problem Description
As reported by the user facility: event 2: description: had to keep switching out lines during a surgery as they kept getting air in the lines.No injury reported.
Additional Manufacturer Narrative
Event 2: this report has been identified as b.Braun medical internal report number (b)(4).No sample was provided for evaluation.Based on the data from the investigation we are unable to determine the root cause of the reported incident.The reported defect was unable to be confirmed.The actual defective device is a valuable tool in investigating the cause of this incident.Review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.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.
Additional Manufacturer Narrative
Event 2: this report has been identified as b.Braun medical internal report number (b)(4).Four unused samples in packaging were returned for evaluation.The samples were visibly evaluated, and no nonconformities were found.The samples were then gravity primed to a bag of solution in an attempt to replicate the reported defect and no air bubbles were found in the tubing.The reported defect was not confirmed.Although the samples met specifications and the air in line could not be replicated, some possible causes related to air in line alarms could be incomplete priming of the iv line, infusion of cold solutions which may exhibit air bubbles coming out of solution as the fluid warms, incomplete filling of the drip chamber during priming, etc.Review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.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.

• Brand Name: IV ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer (Section G): B. BRAUN DOMINICIAN REPULIC INC.; las americas industrial park; km22 autopista las americas; santo domingo ; DR
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 15538195
• Report Number: 2523676-2022-00494
• Device Sequence Number: 6168154
• Product Code: FPA
• UDI-Device Identifier: 04046964188459
• UDI-Public: (01)04046964188459
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K790062
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/28/2022

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 Expiration Date: 04/30/2024
• Device Model Number: V1482
• Device Catalogue Number: V1482
• Device Lot Number: 0061678157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2022
• Supplement Date Received by Manufacturer: 09/06/2022; 09/06/2022
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 10/30/2022; 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2019
• 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