MAUDE Adverse Event Report: EXTENSION SET; SET, ADMINISTRATION, INTRA

Model Number	473041
Medical Device Problem Codes	Leak/Splash (1354); Improper Flow or Infusion (2954)
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 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: "we have noticed blood backflow in our iv lines which was fixed by raising dependent lines and raising pumps higher but this one time, there was blood leakage and air in line due to a crack in the caresite"."no injury to the infant due to the issue.Product was replaced.The baby needed additional level of care and was transferred out due to other medical issues.Unknown outcome.".
Additional Manufacturer Narrative
This report is being submitted to provide the following correction for b.Braun medical internal report number (b)(4)."no sample and/or lot number were provided for evaluation.Further investigation of the complaint is not possible.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: EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRA
• MDR Report Key: 12315665
• Report Number: 2523676-2021-00254
• Device Sequence Number: 4490444
• Product Code: FPA
• UDI-Device Identifier: 04022495770202
• UDI-Public: 04022495770202
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2021

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 Model Number: 473041
• Device Catalogue Number: 473041
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 09/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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