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

Model Number	415110
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The device involved has been received for evaluation and 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: it was reported that black greasy substance was seen on the valve.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number 400458257.One (1) unused sample was returned for evaluation.A photo was also provided.The returned ultrasite valve was visually inspected, and it was noted that a greasy substance was present on the valve.The returned photo displayed the same defect.Therefore, the reported defect was confirmed.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.As a result of this occurrence, a formal awareness training session was conducted with all applicable personnel involved in the assembly and inspection of this product.The purpose of this training was to review the reported incident and to ensure all personnel understand and comply with the established assembly and inspection processes.Incidents of this nature are attributed to operator oversight during the manufacturing of the product.Although our training procedures ensure that all of our employees are properly trained in their areas of responsibility, an oversight on the part of the operator can attribute to an incident of this nature.

• Brand Name: ULTRASITE
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 9595931
• Report Number: 2523676-2019-00241
• Device Sequence Number: 11368509
• Product Code: FPA
• UDI-Device Identifier: 04022495769923
• UDI-Public: 04022495769923
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K031923
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2020

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: 06/30/2024
• Device Model Number: 415110
• Device Catalogue Number: 415110
• Device Lot Number: 0061685793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 02/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1