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

Catalog Number	473036
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported from medwatch (b)(4): describe the event or problem: patient was started on paclitaxel with filter intact.After a few seconds of starting the pump, the registered nurse (rn) noticed the connection site was leaking and double checked.She quickly notified the primary rn/team lead (tl).The blue drip-free connector was changed, and it was determined the leaking was still occurring at the filter site.Leak was constituted of saline in the primed line and caught early before chemo actually filled the tubing.Pharmacy was promptly notified.Medication was disconnected from patient and sent back down to pharmacy for tube change/filter priming.Medication arrived with new tubing/new filter in place.Medication was restarted with 2-rn verifier.Connection site monitored for further leaking, and it was determined the leak was no longer present.Pharmacy notified to keep filter connector for lot info for incident tracking.Equipment provided to director.
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.
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.The retain samples for item# 473036 and lot# 0061876546 were visually inspected and physically tested for leakage and result was that 05 out of 05 samples were found acceptable with passing results.Therefore, the defect of leakage reported by the customer could not be confirmed in the retain samples.Two samples were returned for evaluation.However, the products returned were not manufactured by b.Braun.As such, testing could not be conducted and the reported defect was not confirmed.A possible root cause could not be determined.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: FILTERFLOW®
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 861 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18705272
• Report Number: 2523676-2024-00151
• Device Sequence Number: 5943939
• Product Code: FPA
• UDI-Device Identifier: 04022495770196
• UDI-Public: (01)04022495770196
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K942988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2024

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: 473036
• Device Lot Number: 0061876546
• 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: 02/01/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Race: White