MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. ULTRASITE®; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	473448
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
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: "a patient was having a procedure done in x-ray and while the nurse was injecting into product 473448, it blew apart.When the extension set came apart, the patient did bleed onto the stretcher.A ct chest w/ iv contrast (omnipaque 300) was performed.A medrad pressure injector was used at a rate of 3 ml/sec.Patient's arm was fully extended during infusion with no kinks in the tubing.After the incident, the extension set was replaced with new extension set and the exam was done with no problems.".
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the actual sample a thorough sample analysis could not be performed and no specific conclusions can be drawn.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.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: ULTRASITE®
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown 18109
• MDR Report Key: 8634007
• Report Number: 9614279-2019-00081
• Device Sequence Number: 2005139
• Product Code: FPA
• UDI-Device Identifier: 04046964185366
• UDI-Public: 04046964185366
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K955585
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2019

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: 12/31/2023
• Device Catalogue Number: 473448
• Device Lot Number: 0061658494
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/08/2019
• Supplement Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR