MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. INFUSOMAT®; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	363421
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	07/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used sample without packaging was returned for evaluation.The sample was visually evaluated and the tip of the proximal backcheck valve was broken inside the caresite.Based on the results of the sample evaluation, the reported defect is not confirmed to be a manufacturing defect.An exact root cause cannot be determined.The most likely potential cause is that the defect originated from excessive force being placed on the valve during use.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.Note: the original initial mdr for this case was inadvertently submitted via the "test" account of the fda electronic submission gateway (esg) webtrader.As the original submission was not submitted through the "production" account of the fda esg webtrader, a new initial mdr submission is required per zoom call with sameer phanase of the fda esg help desk.
Event or Problem Description
As reported by user facility, the tubing separated near the valve after the infusion was completed and disconnected from the veteran.Specifically, it was noted that the distal portion of the tubing at the lower lure access and anti-siphon valve had separated.The separation occurred after the infusion had completed and when it was disconnected from the veteran.The nurse stated there was no difficulty in disconnecting the line, with no forceful action in disconnecting the line from the veteran.As she put it, "it caught me off guard and was completely unexpected".

• Brand Name: INFUSOMAT®
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer (Section G): B. BRAUN DOMINICAN REPUBLIC INC.; las americas industrial park; km 22 autopista las americas; santo domingo, ; DR
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 20398140
• Report Number: 2523676-2024-00728
• Device Sequence Number: 3579545
• Product Code: FPA
• UDI-Device Identifier: 04046964294617
• UDI-Public: (01)04046964294617
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K142036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/08/2024

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 Catalogue Number: 363421
• Device Lot Number: 0061928860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2024
• 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