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

Catalog Number	354207
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: details of complaint (reported issue): problem information bubbles in the iv line "the bubbles are forming pre and post the filter.I am suspicious they are coming from the injection ports as i can hear a "fizz" sound, but i also think it's happening at the filter as well.I can prime the whole line without bubbles and then new one's form while i am running a drip.I am not using the injection ports, so this is just while running an iv bag from the top" occurrences: 1 ea.
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.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Twelve samples in original used packaging were provided for evaluation.Upon visual inspection of the returned sample, no defects were observed.The samples were attached to the pump to check for compatibility.The tubing fit without needing to be stretched, and there was no interference between the tubing couplers and the pump housing.To replicate the reported air-in-line alarm defect, the sample was attached to the pump and tested by running therapy with varying flow rates.No alarms were triggered during this testing.Additionally, the samples were leak tested, and no leaks were detected.The outer diameter (od) of the pump segment tubing was measured to be within specification.Based on the data from the investigation, the reported defect was unable to be confirmed.The root cause was unable to be determined, a 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: CARESITE®
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 19519237
• Report Number: 2523676-2024-00613
• Device Sequence Number: 8337256
• Product Code: FPA
• UDI-Device Identifier: 04046964182136
• UDI-Public: (01)04046964182136
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K942988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

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 Catalogue Number: 354207
• Device Lot Number: 0061920526
• 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: 06/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2024
• 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