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

Catalog Number	470107
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event 1: (b)(4).As confirmed by the user facility, no sample is available for evaluation.The investigation is ongoing at this time.A follow-up report will be submitted when the results of the investigation become available.
Event or Problem Description
As reported by the user facility: event 1: during administration, the extension set leaked chemotherapy.Leakage occurred at the primary set connection and at the leur lock connection on the y-site.No patient injury.
Additional Manufacturer Narrative
Event 1: this report has been identified as b.Braun medical internal report number (b)(4).No samples were returned for evaluation in connection with this incident.Without the actual device, a thorough investigation could not be performed.Review of the discrepancy management system (dsms) database performed for the reported lot number revealed no abnormalities or non-conformances noted during in process or final product inspection.We will maintain this report for further references 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.

• 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: 8047901
• Report Number: 9614279-2018-00192
• Device Sequence Number: 1525974
• Product Code: FPA
• UDI-Device Identifier: 04046964183911
• UDI-Public: 04046964183911
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K942988
• 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,Followup
• Report Date (Section B): 12/14/2018

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 Expiration Date: 04/30/2021
• Device Catalogue Number: 470107
• Device Lot Number: 0061622146
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 12/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1