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

Catalog Number	415122-01
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 b.Braun global affiliate: i wanted to bring to your attention an issue regarding the bungs from the batch number.Unfortunately, we've encountered faults with these bungs, and this appears to be a recurring problem, rather than an isolated incident.I can confirm that i have three boxes with the batch number of the faulty bungs.Batch no.0061966919 i'm really concerned about patient safety, as we administer chemotherapy, and any leakage from these bungs could cause harm to our patients.Can we urgently look into this? update from customer; in terms of the 3 incidents you mention, were these all experienced using bungs from the same batch no.0061966919? - yes.1.Was there any patient/user harm because of the incident? if so, please provide further clinical information such as patient outcome and any additional therapy required as a result.- no harm.2.Which procedure was being carried out at the time? - picc dressing change.3.Was there any delay to the procedure because of this incident? if so, please quantify as accurately as possible.- no significant delays.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One hundred and ninety-five caresite units and two photographs were provided for investigation.Upon evaluation of the photographs, they depicted the label with the item#, lot#, and expiration date along with inner shipping boxes.However, no definitive conclusions can be drawn based on the provided images.All returned samples were visually examined with no defects observed.Leakage testing was performed with passing results.The reported concern was not confirmed.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, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown PA 18109
• Manufacturer (Section G): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 21731228
• Report Number: 2523676-2025-00307
• Device Sequence Number: 21032079
• Product Code: FPA
• UDI-Device Identifier: 04046964115998
• UDI-Public: (01)04046964115998(11)241104(17)271031(10)0061966919
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K140311
• 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): 04/30/2025

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: 415122-01
• Device Lot Number: 0061966919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2024
• 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