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

Model Number	470101
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as event 2 of 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
Event 2: as reported by the user facility: "the connection came apart during power injections.The connection came apart after most of the injection was completed.The instance involved some blood to return and created a potential exposure.".
Additional Manufacturer Narrative
This report has been identified as event 2 of b.Braun medical internal report number (b)(4).One (1) photo was provided for evaluation.Upon visual inspection of the photo, neither a disconnect or leakage was able to be identified.Based on the data from our evaluation, the exact nature of the reported defect could not be determined at this time.Review of the discrepancy management system (dsms) database performed for the reported lot number revealed no abnormalities or non-conformances noted during in process or final product inspection.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If additional pertinent information becomes available, a follow-up will be submitted.

• Brand Name: CARESITE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown 18109
• MDR Report Key: 10837849
• Report Number: 2523676-2020-00318
• Device Sequence Number: 14179179
• Product Code: FPA
• UDI-Device Identifier: 04046964183874
• UDI-Public: 04046964183874
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K083723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2020

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: No Information
• Device Expiration Date: 04/30/2023
• Device Model Number: 470101
• Device Catalogue Number: 470101
• Device Lot Number: 0061736110
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1