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

Catalog Number	352904
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).As reported by the user facility, it was confirmed that the sample is not available for 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.
Event or Problem Description
As reported by the user facility: customer reports problem with air being pulled from the upper y into tubing when running on vita basic pump.The air bubbles causes the pump to alarm, which it should, but small air bubbles are often seen from upper y.No injury reported.

• Brand Name: SAFEDAY¿
• 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: 7687424
• Report Number: 9614279-2018-00102
• Device Sequence Number: 1316249
• Product Code: FPA
• UDI-Device Identifier: 04046964181993
• UDI-Public: 04046964181993
• Combination Product (Y/N): N
• PMA/510(K) Number: K955585
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/13/2018

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: 01/31/2021
• Device Catalogue Number: 352904
• Device Lot Number: 0061605713
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 07/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1