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

Catalog Number 415126

Device Problem Leak/Splash (1354)

Patient Problem Chemical Exposure (2570)

Event Date 10/20/2023

Event Type  malfunction  

Event Description

As reported by the user facility: description of malfunction/failure: on october 20, 2023, at 18:30, when cytarabine was administered to patient, clothes were wet, picc line was closely connected, and there was leakage in the ultrasite injection site.The ultrasite injection site was replaced, and there was no leakage.Reported to the doctor on duty, about 10ml of fluid leaked.Description of root cause analysis (by reporter): the connection between the screw connector of infusion set and the ultrasite injection site was not smooth.After several connections, the ultrasite injection site showed no obvious fracture, but there was liquid leakage.Preliminary handling of event: change the ultrasite injection site and continue the infusion.No injury reported.

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.

• Brand Name: CARESITE®
• Type of Device: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer (Section G): B. BRAUN DOMINICIAN REPULIC INC.; las americas industrial park; km22 autopista las americas; santo domingo, ; DR
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18145091
• MDR Text Key: 329648352
• Report Number: 2523676-2023-00727
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K140311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/15/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 415126
• Device Lot Number: 0061862981
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2023
• Initial Date FDA Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Sex: Female