MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. CONNECTOR; ADAPTOR, STOPCOCK, MANIFOL

Catalog Number	456080
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: nkarta has observed particles during the cell therapy manufacturing process.A critical investigation has been initiated to further determine root cause of the particulates and to potentially identify the source(s).A third party analysis was performed on particulate samples and characterization of particles include: pet polyester.Cellulose; colored (yellow, tan, blue) and colorless.Nylon.Nkarta has identified vendors that provide materials upstream of the manufacturing process incident that may have contributed to the particulates found.Additional information provided: the particle was isolated in our manufacturing process.We cannot determine if the particle originated from the fluid path or non-fluid path of the double male luer.We identified the double male luer as a component that was used upstream before the particle was isolated.Hence, why we sent a supplier questionnaire related to material of contruction (moc) of the double male luer to see if the particle may have originated from the double male luer itself.No injury reported.
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.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 reported defect was unable to be confirmed.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: CONNECTOR
• Common Device Name: ADAPTOR, STOPCOCK, MANIFOL
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18151877
• Report Number: 2523676-2023-00741
• Device Sequence Number: 5671295
• Product Code: DTL
• UDI-Device Identifier: 04046964183669
• UDI-Public: (01)04046964183669
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K942391
• 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): 05/01/2024

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: 456080
• Device Lot Number: 0061835830
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2022
• 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