MAUDE Adverse Event Report: FOUNTAIN®; CATHETER, CONTINUOUS FLUSH

Model Number	00884450011676
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that after placing anticoagulation in a left iliac venous indwelling catheter to maintain vascular access, the patient developed a high fever.Blood culture came back positive due to long term use of the device.The catheter was removed and antibiotics administered.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: FOUNTAIN®
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• MDR Report Key: 12700111
• Report Number: 1721504-2021-00076
• Device Sequence Number: 1467492
• Product Code: KRA
• UDI-Device Identifier: 00884450011676
• UDI-Public: 00884450011676
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K974067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/06/2024
• Device Model Number: 00884450011676
• Device Catalogue Number: FIS4-135-50SQ/CN
• Device Lot Number: H2069858
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/22/2021
• Supplement Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 11/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention