MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. CARESITE; SET, ADMINISTRATION, INTRA

Model Number	470108
Medical Device Problem Code	Improper Flow or Infusion (2954)
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).Although the device involved is not available for evaluation, video's were provided, 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: customer reported that additional priming with saline is done due to air back flowing into the tubing after priming it initially.Also the clamp is harder to close.Details of the report: "even after priming with more saline than usual the nurses are having to clamp off the tubing to prevent air backflow into the patients' veins which wasn't an issue with the old tubing.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).During a follow up the customer confirmed that the item they are having issues with is item 470124.The item previously reported had no issues.This report was updated to be against item number 470124, no lot number was provided.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Two videos were provided for evaluation.Visual examination of the provided videos noted that the extension set was attempted to be primed without being connected to any device.After the attached syringe was depressed the fluid would move back into the syringe.Based on the evaluation of the videos the reported defect is not confirmed.It should be noted that the reported item is meant for use with power injectors.Per the ifu, it states, "firmly attach connectors to desired connections.Prime extension set to ensure air is expelled." 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: CARESITE
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 9694005
• Report Number: 2523676-2020-00039
• Device Sequence Number: 1742510
• Product Code: FPA
• UDI-Device Identifier: 04046964093753
• UDI-Public: 04046964093753
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K083723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2020

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 Model Number: 470108
• Device Catalogue Number: 470108
• Initial Date Received by Manufacturer: 01/24/2020
• Supplement Date Received by Manufacturer: 01/24/2020; 01/24/2020
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 03/24/2020; 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1