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

Catalog Number	354205
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
Event 2: (b)(4).No sample was returned for evaluation in connection with this incident.Without the actual device, a thorough investigation could not be performed.The lot number was reported as unknown.However, the user facility identified the lot numbers that were in stock as the following: 0061617297, 0061603420, 0061609494, and 0061605826.Review of the discrepancy management system database performed for the reported potential lot numbers did not reveal any abnormalities or non-conformances of this nature.We will maintain this report for further reference and continue to monitor other reports for similar occurrences.If a sample and/or any additional pertinent information becomes available, a follow up will be submitted.Event 1 was reported via 9614279-2018-00145.
Event or Problem Description
As reported by the user facility: event 2: the tubing broke which caused the carboplatin to leak.No injuries reported.

• Brand Name: CARESITE®
• 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: 7852879
• Report Number: 9614279-2018-00146
• Device Sequence Number: 19329437
• Product Code: FPA
• UDI-Device Identifier: 04046964182099
• UDI-Public: 04046964182099
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K083723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/06/2018

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: 354205
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1