MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. MULTI-AD®; DISPENSER, LIQUID MEDICATI

Model Number	513501
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample and/or lot number was provided for further evaluation.Without the actual device and/or lot number, 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 identified another particle in an ampicillin/sulbactam 40mg/ml dilution.Customer stated that they have continued to find small particles dilution bags.Some technicians stated that they only can see these particles in the bag after a day or two from initial production.No injury reported.

• Brand Name: MULTI-AD®
• Common Device Name: DISPENSER, LIQUID MEDICATI
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown, pa
• MDR Report Key: 9800841
• Report Number: 2523676-2020-00064
• Device Sequence Number: 643461
• Product Code: KYX
• UDI-Device Identifier: 04022495770387
• UDI-Public: 04022495770387
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K792227
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2020

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: 513501
• Device Catalogue Number: 513501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1