MAUDE Adverse Event Report: B. BRAUN MEDICAL INC.; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	7G0400
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: event 3: three (3) defects for loose foreign material were observed during incoming inspection.
Additional 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.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Seven pictures were provided alongside seven samples for evaluation.Upon visual inspection of the images, loose particulates were observed in all cases.The returned samples were then examined using optical equipment per specification, and loose particulates were identified on each sample.Based on the findings from both the image and sample evaluations, the reported defect was confirmed.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.A visual inspection was performed on the retained samples, and no defects were observed.Therefore, the defect of loose foreign particulates reported by the customer could not be confirmed in the retain samples.Through evaluation of the manufacturing process of the reported lot, it was found that the sub-component materials went through reworks.This means there was extra handling of the parts outside of the normal manufacturing process.Therefore, the potential root cause of this issue could be additional the handling which then introduced the foreign material onto the spikes.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: NA
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 824 12th ave; bethlehem, PA 18018 ; 4847197287
• MDR Report Key: 22059670
• Report Number: 2523676-2025-00498
• Device Sequence Number: 7812022
• Product Code: FMI
• UDI-Device Identifier: 04046964345388
• UDI-Public: (01)04046964345388(11)250312(17)300228(10)00VL994743
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K801108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2025

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: 7G0400
• Device Lot Number: 00VL994743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2025
• 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