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

Catalog Number	470106
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 not 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: event 1: there were 2 incidences on 2 different patients, both incidents were infusing methotrexate and bicarb.During the infusion, the extension set started leaking.The second incident is captured under report number 9614279-2017-00100.No injuries reported.
Additional Manufacturer Narrative
Event 1: this report has been identified as b.Braun medical internal report number (b)(4).Two (2) used samples without packaging were returned for evaluation.Upon visual examination, a crack was observed on the female threads of the caresite valves, on each extension set.The returned samples visually confirmed the reported complaint of leakage due to a crack in the threads of the caresite valves.Due to this complaint and other confirmed complaints of this nature, b.Braun medical has initiated a corrective action/ preventative action (capa) to address the issue of "leakage" involving the caresite valve.Review of the discrepancy management system database was unable to be performed because the lot number was reported as unknown.We will maintain this report for further references and continue to monitor other reports for similar occurrences.

• 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: 6976450
• Report Number: 9614279-2017-00099
• Device Sequence Number: 11130280
• Product Code: FPA
• UDI-Device Identifier: 04046964093739
• UDI-Public: 04046964093739
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2017

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: 470106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/16/2017
• Supplement Date Received by Manufacturer: 10/16/2017
• Initial Report FDA Received Date: 10/25/2017
• Supplement Report FDA Received Date: 11/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1