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

Catalog Number	473992
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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: there was a crack on the filter of the extension set causing chemo to leak during use.Chemotherapy being infused was etoposide, doxorubicin, and vincristine.
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 no crack or other defects were noted.The returned set was tested for leakage per specification with failing results.Leakage was noted through the air vent holes of the 0.2 micron air eliminating filter.The defect of leakage was able to be confirmed through physical testing.Further examination by the manufacturer noted that the vent membrane was wetted out.Review of the discrepancy management system database was unable to be performed because the lot number was reported as unknown.While we are unable to determine the root cause of the reported defect, 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 DOMINICAN REPUBLIC INC.; las americas industrial park; km22 autopista las americas; santo domingo, ; DR
• MDR Report Key: 6871093
• Report Number: 9614279-2017-00079
• Device Sequence Number: 10878072
• Product Code: FPA
• UDI-Device Identifier: 04046964185465
• UDI-Public: 04046964185465
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K955585
• 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): 08/21/2017

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: 473992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/21/2017
• Supplement Date Received by Manufacturer: 08/21/2017
• Initial Report FDA Received Date: 09/15/2017
• Supplement Report FDA Received Date: 10/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1