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

Catalog Number	354205
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	08/29/2024
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: brief inquiry description: roller clamp not working.Detailed inquiry description: customer says that roller clamp is not working.To the point, that she had to close the roller clamp to keep it from free flowing.This caused an iv to dry up right before starting the procedure.Customer had to start another iv in or after patient was a difficult stick.The roller clamp has not worked properly on any of their tubing.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One unused sample in open packaging was provided for evaluation.Upon visual inspection of the received sample, no visual discrepancies were noted.The sample was then leak tested with no leakages observed.In an attempt to replicate the defect, the sample was gravity primed and attached to an iv bag to observe if the roller clamp fully occluded the tubing when applied.During testing, the roller clamp was put into the open and closed position and no functional issues were noted as well.Based on the investigation, the defect reported was not confirmed.The root cause of the reported incident 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 (Section G): B. BRAUN DOMINICAN REPUBLIC 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: 20303805
• Report Number: 2523676-2024-00852
• Device Sequence Number: 21049527
• Product Code: FPA
• UDI-Device Identifier: 04046964182099
• UDI-Public: (01)04046964182099
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K083723
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2024

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: 354205
• Device Lot Number: 0061944272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2024
• 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