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

Catalog Number	473995
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 via medwaych number mw5084697: patient's blood was backing up in the uvc line and fluid tubings.Lipid filter was half way empty.Line was flushed and filter was replaced.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).As reported by the user facility, it has been confirmed that no samples are available for further evaluation.Without the actual device, a thorough investigation could not be performed.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.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or lot number.

• Brand Name: FILTERFLOW®
• 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: 8483153
• Report Number: 9614279-2019-00032
• Device Sequence Number: 1471104
• Product Code: FPA
• UDI-Device Identifier: 04046963363024
• UDI-Public: 04046963363024
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K942988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2019

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: 11/30/2023
• Device Catalogue Number: 473995
• Device Lot Number: 0061652276
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 04/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1