MAUDE Adverse Event Report: B. Braun Medical Inc. SAFELINE®; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	NF9100
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 complaint has been identified as b braun medical internal complaint number (b)(4).Forty-six unused samples were returned for evaluation.Upon receipt of the returned samples, a visual evaluation was conducted in accordance with the applicable specification.No visual defects were observed during the evaluation.Furthermore, the samples were subjected to leak testing per the applicable specification, with all samples demonstrating acceptable results.Additionally, in order to replicate the reported incident, each sample was punctured multiple times with a needle and subsequently re-tested for leakage.No leakage was observed following multiple punctures.Based on the samples evaluation, the product met internal specifications.

• Brand Name: SAFELINE®
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. Braun Medical Inc.; 824 12th ave; bethlehem PA 18018
• Manufacturer (Section G): B. Braun Medical Inc.; 824 12th ave; bethlehem PA 18018
• Manufacturer Contact: elena reifenstein ; 824 12th ave; bethlehem, PA 18018 ; +1(833)425-1464
• MDR Report Key: 50611607
• Report Number: 2521402-2026-00828
• Device Sequence Number: 10605906
• Product Code: FPA
• UDI-Device Identifier: 04046964187520
• UDI-Public: (01)04046964187520(11)230220(10)0061875568
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K931377
• 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,Followup
• Report Date (Section B): 09/25/2026

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: NF9100
• Device Lot Number: 0061875568
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/28/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2023
• 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