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

Model Number	470117
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2020
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
As reported by the user facility: "the treating nurse attached the bag to the patient and drug [paclitaxel] started to leak at the point of connection of the tubing and extension set.Pharmacy staff examined the connections and they were tight.".
Additional Manufacturer Narrative
Event 2: this report has been identified as b.Braun medical internal report number (b)(4).No sample was provided for further evaluation.The reported defect was not confirmed.Based on the data from the investigation we are unable to determine the root cause of the reported incident via the photo.Review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.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: CARESITE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown 18109
• MDR Report Key: 10779099
• Report Number: 2523676-2020-00308
• Device Sequence Number: 13737702
• Product Code: FPA
• UDI-Device Identifier: 04046964183997
• UDI-Public: 04046964183997
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K942988
• 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): 12/23/2020

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 Expiration Date: 07/09/2023
• Device Model Number: 470117
• Device Catalogue Number: 470117
• Device Lot Number: 0061740576
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1