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

Catalog Number	473995
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).No sample was available for further evaluation.Without the actual device, a thorough investigation could not be performed.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 via medwatch number: mw5088368.Event 1: " rn was hanging sterile fluids for central line fluid change when the filtered extension set was found to be fill with air despite being primed with fluid.Rn removed filter from primed line and replaced with a functional filter set prior to attaching to patient." no injury reported.

• Brand Name: FILTERFLOW®
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN DOMINICIAN REPULIC INC.; las americas industrial park; km22 autopista las americas; DR
• MDR Report Key: 8981258
• Report Number: 9614279-2019-00141
• Device Sequence Number: 364993
• 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
• Report Date (Section B): 09/10/2019

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: 03/31/2024
• Device Catalogue Number: 473995
• Device Lot Number: 0061673125
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 09/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1