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

Catalog Number	354207
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Dizziness (2194)
Date of Event	10/28/2023
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: details of complaint (reported issue): patient was connected to iv line post iv insertion, blood flowed back up the tubing (tourniquet was off), and then continued to leak out of tubing.Patient was disconnected and i connected them to a saline lock which i luckily had right beside me.Patient did go vasovagal with light headiness and looked slightly pale.I believe the leak was with the iv tubing and not flow regulator, but i could not exactly pinpoint at what site.My first thought when i noticed the blood flow return was the connection was loose but when i tightened it continued to flow upwards then started leaking.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).A 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.No sample was provided for evaluation.Based on the data from the investigation we are unable to determine the root cause of the reported incident.The reported defect was unable to be confirmed.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, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18151310
• Report Number: 2523676-2023-00748
• Device Sequence Number: 6721112
• Product Code: FPA
• UDI-Device Identifier: 04046964182136
• UDI-Public: (01)04046964182136
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2024

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: 04/30/2025
• Device Catalogue Number: 354207
• Device Lot Number: 0061829317
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/04/2022
• 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
• Patient Sex: Unknown