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

Model Number	362004
Medical Device Problem Code	Fluid/Blood Leak (1250)
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).The device involved has not been received for evaluation and 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: "during use on a patient, the line was connected to a primary tubing and it leaked at the first y-connector above the luer lock connector.No injury to the patient or user, just waste of chemotherapy agent." no injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).A sample was not returned 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 any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: INFUSOMAT
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown, pa
• MDR Report Key: 9716753
• Report Number: 2523676-2020-00042
• Device Sequence Number: 11545465
• Product Code: FPA
• UDI-Device Identifier: 04046964293931
• UDI-Public: 04046964293931
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2020

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: 362004
• Device Catalogue Number: 362004
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 02/17/2020
• Supplement Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1