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

Catalog Number	415110
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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: customer reports that the ultrasite valve leaked chemotherapy during use.The leak was not discovered until the end of therapy because patient was under a blanket.The patient did not require any additional treatment due to the chemo leaking.Chemotherapy being infused were vincristine and doxorubicin.A chemo spill kit was used to clean up the leak.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used sample without packaging was returned for evaluation.Upon visual inspection a crack was noted on the threads of the ultrasite.The ultrasite was tested for leakage per specification with failing results.The valve was found to be leaking at the site of the crack.The defect of leakage was confirmed through physical testing.Review of the discrepancy management system database was unable to be performed because the lot number was reported as unknown.Although the defect of leakage was confirmed on the ultrasite valve, the exact root cause of the crack was not able to be determined at this time.We will maintain this report for further references and continue to monitor other reports for similar occurrences.

• 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: 6927862
• Report Number: 2523676-2017-00157
• Device Sequence Number: 19145198
• Product Code: FPA
• UDI-Device Identifier: 04022495769923
• UDI-Public: 04022495769923
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2017

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: 415110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/22/2017
• Supplement Date Received by Manufacturer: 09/22/2017
• Initial Report FDA Received Date: 10/08/2017
• Supplement Report FDA Received Date: 10/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 6 YR