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

Catalog Number	471960
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: brief inquiry description: leaking ext set.Detailed inquiry description: when flushed or infusing, leaks where connected to t-connector.Upon giving bedside report on (b)(6) 2025 at 07:30 it was noted that there was a small damp spot on patient blanket.A small amount of blood was noted in the t-connector.Blanket was not sticky, but decision made by night and day shift nurse to flush iv.Patient did not appear to have any other source for wetness at the time (wrong location for drool or emesis or og tube aspirate).Upon flushing iv, fluid spurted out of a tiny crack in the green hub colored t-connector.Iv was taken down to the yellow hub.Aseptic technique used.New t-connector attached.Iv secured with new tegaderm and tape.Piv flushed without difficulty.Piv infusion of d10% continued without delay.Immediately placed faulty t-connector in to a bag with flush attached.Piv had been placed the day before and packaging for t-connector was unable to be located.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One used sample without packaging was provided for evaluation.The returned sample was visually evaluated.It was noted that the sample was attached to a syringe, and upon detachment, a crack was observed on the green connector.Based on the results of the sample evaluation, the defect has been determined to be caused by further processing performed during use.The defect is not confirmed to be caused by the manufacturing process.All available information regarding this occurrence has been forwarded to our business unit in order to heighten awareness.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: EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 21678997
• Report Number: 2523676-2025-00270
• Device Sequence Number: 7739943
• Product Code: FPA
• UDI-Device Identifier: 04022495770127
• UDI-Public: (01)04022495770127
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K153293
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2025

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: 471960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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