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

Catalog Number 363421

Device Problem Leak/Splash (1354)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 10/03/2023

Event Type  Injury  

Event Description

As reported by the user facility: brief inquiry description: leaking tubing by y-site.Detailed inquiry description: patient at levophed max dose and remained hypotensive.Pt at eol and dnr/dni so when blood pressure was dropping additional life-saving measures not taken.After expiration, registered nurse found cracked tubing and fluid on sheets.

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.

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.Two (2) used samples and one (1) photo were submitted to the manufacturer for evaluation.Through visual examination of the photo, it was noted that there was fluid shown in the photo with the sample, however it is difficult to determine where the leakage is coming from.Through visual examination of the samples, no damages or defects were observed.The samples were then leak tested; the results of the test noted that the samples had passing results.In addition, a luer taper test was performed on the patient connectors with passing results.To replicate the reported defect, a patient connector was attached to all y-care sites and leakage was observed at the connection on the proximal care site and patient connector.The leaking caresite was placed under magnification and it was noted a vertical crack at one of the samples.Although a vertical crack was found on the used returned sample, an exact root cause could not be determined at this time.However, incidents of cracked/leaking valves may be caused by several factors, including the product being subjected to aggressive solvents/drugs, excessive mechanical stresses (over-tightening or frequent set manipulation), or other various unforeseen circumstances during the clinical application.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.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).Correction: section h6 - removed 3331 - analysis of production records from "type of investigation".Added 4112 - analysis of data provided by user/third party to "type of investigation".Section h10: "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." - this line was entered in error.It should not be a part of the manufacturer narrative.

• Brand Name: INFUSOMAT®
• 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: 18066238
• MDR Text Key: 327295997
• Report Number: 2523676-2023-00619
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 04046964294617
• UDI-Public: (01)04046964294617
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 363421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2023
• Initial Date FDA Received: 11/03/2023
• Supplement Dates Manufacturer Received: 10/05/2023; 10/05/2023
• Supplement Dates FDA Received: 12/27/2023; 12/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Other