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

Catalog Number	354221
Medical Device Problem Code	Leak/Splash (1354)
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: brief inquiry description: iv filter set chemo spill.Triple chemo (adriamycin, vincristine, and cytoxan) detailed inquiry description: end user reports chemo spill with our filter set.Where was the set leaking from specifically (appears to be air filter)? leaking believed to occur around the 20th (19-23rd hr) hour of the infusion.In latest infusion, they gave over 12hrs instead of 24hrs and no leaking occurred.Air vent on flat side of filter, not the "house" side.Leaking occurred with the same patient every time.The same medication infusion was given to other patients in the same time frame with no leaking.We use b.Braun pumps and there were no reported alarms during the infusion.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Three photos were provided for further evaluation.The photos were visually evaluated, and it was noted only the used air-eliminating filter was shown.The provided picture does not offer the details necessary to confirm the reported defect or determine any root cause at this time.Based on the evaluation results, the reported defect was unable to be confirmed.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 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.

• 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 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: 17772361
• Report Number: 2523676-2023-00558
• Device Sequence Number: 20588678
• Product Code: FPA
• UDI-Device Identifier: 04046964182372
• UDI-Public: (01)04046964182372
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2023

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: Health Professional
• Device Expiration Date: 09/30/2025
• Device Catalogue Number: 354221
• Device Lot Number: 0061856392
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2022
• 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