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

Catalog Number	415110
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample and/or lot number were provided.Further investigation of the complaint is not possible without a sample and/or lot number.The actual defective device is valuable tool in investigating the cause of this incident.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.
Event or Problem Description
As reported per medwatch mw5148280: the patient reported that she was having some bleeding that was coming from the area around connection from her ultrasite valve and cadd ext set.The patient stated that her line was well fastened and she couldn't tell where the issue was coming from.The patient reported that she had already replaced her valve and line and everything seems to be working fine.The patient stated her main concern was that she had this issue about 3 weeks ago, but she never reported it and wanted to know if there have any reports of similar issues or if there was a recall of either item.Patient had no other questions/concerns at this time.The patient did not miss any doses as a result of issue.Adverse event dates are unknown.The outcome of this event is unknown as pt did not report event dates unknown as pt didn't report them.Lot number and expiration date are unknown.No further information is known or given.Reference report mw5148279.Reported to (b)(6) by: pateint/caregiver.Brand name: ultra site 2 way capless valve common device name: set, administration, intravascular product code: fpa model #: 415110 type of event: serious injury health effect - clinical code(s): 1888: hemorrhage/blood loss/bleeding.

• Brand Name: ULTRASITE®
• 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: 18344447
• Report Number: 2523676-2023-00847
• Device Sequence Number: 6202654
• Product Code: FPA
• UDI-Device Identifier: 04022495769923
• UDI-Public: (01)04022495769923
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K031923
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/18/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 415110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 12/18/2023
• 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
• Patient Sex: Unknown