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).No sample and/or lot number were provided.Further investigation of the complaint is not possible without a sample and/or lot number.The actual defective device is valuable tool in investigating the cause of this incident.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 patient: we received a complaint from a patient regarding the new b.Braun rate flow sets.Patient feels the new set involves a safety risk.I'm not aware of any gravity tubing that stops the flow once the bag is empty.See patient comments below: "i just used the new tubing provided for the gravity.It is a major risk / concern.The old tubing would not continue once the bag was empty and did not allow air into the tubing.This new one however did and the air made it past the dial and was on its way into my heart when i caught it.It appears to me based upon this experience this tubing is unsafe." no injury reported.

• 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 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: 18026658
• Report Number: 2523676-2023-00636
• Device Sequence Number: 15370082
• Product Code: FPA
• UDI-Device Identifier: 04046955257164
• UDI-Public: (01)04046955257164
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2023

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 Catalogue Number: 375257
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 10/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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