MAUDE Adverse Event Report: B. BRAUN DOMINICAN REPUBLIC INC. EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	471954
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).Ten of the received samples from lot 0061555072 were visually examined per specification with no efects noted.Those ten samples were occlusion and leakage tested per specification with passing results.The returned unused sets did not confirm the reported defect of leakage.Review of the discrepancy management system database performed for the reported lot number 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.
Event or Problem Description
As reported by user facility: while administering the electrolyte solution to a nicu patient, the nurse found that the female luer was cracked causing about 5ml of blood to leak.

• Brand Name: EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN DOMINICAN REPUBLIC INC.; las americas industrial park; km22 autopista las americas; santo domingo, ; DR
• Manufacturer (Section G): B. BRAUN DOMINICAN REPUBLIC INC.; las americas industrial park; km22 autopista las americas; santo domingo, ; DR
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 7710344
• Report Number: 9614279-2018-00126
• Device Sequence Number: 11480596
• Product Code: FPA
• UDI-Device Identifier: 04022495770103
• UDI-Public: (01)04022495770103
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K942988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2021

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: 02/28/2022
• Device Model Number: 471954
• Device Catalogue Number: 471954
• Device Lot Number: 0061555072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2018
• Supplement Date Received by Manufacturer: 03/06/2018
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 07/23/2018
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown