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

Model Number	470124
Medical Device Problem Code	Fluid/Blood Leak (1250)
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 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 spin lock connector is difficult to attach to the iv catheter.The shape appears different than the prior version of the set with the blue clamp, causing leakage of blood and fluid out of the iv catheter due to misconnections.".
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Multiple photographs of the set were provided for evaluation.The spin lock connectors displayed in the photograph are the same item, per the product drawing.There were no changes made to the spin lock connector used on the set.The purple slide clamp appears to be intact with no damage noted.Based on the evidence provided the reported defect is unable to be confirmed.  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: 11019755
• Report Number: 2523676-2020-00361
• Device Sequence Number: 13670435
• Product Code: FPA
• UDI-Device Identifier: 04046964298738
• UDI-Public: 04046964298738
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K153293
• 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): 01/26/2021

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: 08/31/2023
• Device Model Number: 470124
• Device Catalogue Number: 470124
• Device Lot Number: 0061748481
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 01/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1