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

Catalog Number	471987
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	09/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).As reported by the user facility, it was confirmed that the sample was not saved, the sample was discarded.Without the actual device, a thorough investigation could not be performed.A review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the 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.
Event or Problem Description
As reported by the user facility: back flow of blood occurred when the customer removed the syringe from the t-port tube after injecting drug solution via the syringe, causing blood to leak.No injury reported.

• Brand Name: SAFSITE®
• 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: 7953690
• Report Number: 9614279-2018-00174
• Device Sequence Number: 1464138
• Product Code: FPA
• UDI-Device Identifier: 04046963790110
• UDI-Public: 04046963790110
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K954123
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/10/2018

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: 11/30/2022
• Device Catalogue Number: 471987
• Device Lot Number: 0061595989
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1