MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG EASYPUMP; PUMP, INFUSION, ELASTOMERIC

Model Number	4540040-02
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as event 2 of b.Braun medical inc.Internal report number (b)(4).The investigation into this reported event is ongoing.A follow-up report will be submitted when the results of the investigation are available.
Event or Problem Description
As reported by the user facility: event 2, black particles on the patient connector.
Additional Manufacturer Narrative
Event 2: this report has been identified as b.Braun medical internal report number (b)(4).Multiple samples were received for evaluation regarding foreign material.Per the investigation results, the samples were identified to contain particulate at different locations.Incidents of this nature are due to failure in the production process.An approved project is in place to further address issues with contamination.In addition, a refresher training was performed with personnel and supplier notifications were sent.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: EASYPUMP
• Common Device Name: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl- braun strabe 1; melsungen, 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl- braun strabe 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 12656522
• Report Number: 9610825-2021-00439
• Device Sequence Number: 19886706
• Product Code: MEB
• UDI-Device Identifier: 04046964448942
• UDI-Public: (01)04046964448942
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K081905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2022

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: 11/01/2025
• Device Model Number: 4540040-02
• Device Catalogue Number: 4540040-02
• Device Lot Number: 20M19GE673
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown