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	No Consequences Or Impact To Patient (2199)
Date of Event	09/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (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: back flow of blood occurred when the valve did not work properly.No injury reported.
Additional Manufacturer Narrative
(b)(4).One (1) used set without packaging and 1 photo was returned for evaluation.Visual examination of the set noted no visual defects.The photo was examined, and no issues were noted.The set was leakage tested per specification with passing results.In order to simulate use of the set, a 20ml original perfusor was filled with water and connected to the reflux valve.The syringe was engaged to empty all the water and disconnected from the set.The set was connected to a water source at the female luer and pressurized at 1 psi.Leakage was noted past the blue plunger and through the valve.The valve was dissected and examined.No issues were noted during examination.The reported defect of leaking valve was confirmed.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.In addition, five (5) retains were visually and physically tested per specification with passing results.The retain samples were found within specifications.While we are unable to confirm the root cause of the reported defect, we will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• 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: 7968808
• Report Number: 9614279-2018-00177
• Device Sequence Number: 1773651
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2018

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: 12/31/2022
• Device Catalogue Number: 471987
• Device Lot Number: 0061602429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2018
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1