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

Catalog Number	375257
Medical Device Problem Code	Air/Gas in Device (4062)
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).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: customer reported that her rateflow admin 15 drop w/1 caresite devices have been only flowing from about 100 - 200ml.  the bags being used to medication about 1000ml.  the medicine completely stops flowing and the patient has to repeatedly open the line to resume the flow of meds.There are a lot of air bubbles in the line (not in the tubing) during flushing of the device.  when she disconnects and primes the tubing there is not air in the tubing itself but there is air on her side.  she has had multiple nurses come out and trouble shoot - the pockets of air only happen when she trying to make the device work.When she flushes to line it seems to work but she has to flush repeatedly to get the 1000ml to work.  the nurses have told her this is happening to her and that sometimes if the line open for  period of time the issue is resolved - this is kind of like flushing it.Supposed to 125 - 130 minutes she cannot run the medicine like this,  the open drip is the only way she can get this to work and it takes two - three hours to infuse the medication.She is infusing just normal saline.She will do impactful meds like iron infusion at the hospital.  the hickman got changes to a port but has been afraid to run medicine through the port.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number(b)(4).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.No sample was provided for evaluation.Based on the data from the investigation, the root cause of the reported incident was unable to be determined.The reported defect was unable to be confirmed.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: RATE FLOW®
• 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 REPUBLIX 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: 18684801
• Report Number: 2523676-2024-00124
• Device Sequence Number: 7242683
• Product Code: FPA
• UDI-Device Identifier: 04046955257164
• UDI-Public: (01)04046955257164
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K202618
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2024

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: Lay User/Patient
• Device Expiration Date: 12/31/2025
• Device Catalogue Number: 375257
• Device Lot Number: 0061858387
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2023
• 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: Female