MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. ALLERGAN 21GA WINGED INF SET; TISSUE EXPANDER AND ACCESSORIES

Catalog Number	7M2802
Medical Device Problem Codes	Break (1069); Dull, Blunt (2407); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
According to the complainant, the new needles have had issues, such as bending, breaking off and being very dull that they are unable to puncture through the skin.No injuries were reported as a result of this issue.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) picture was submitted for evaluation, and a proper evaluation could not be performed from the evidence in the images provided.However, due to the high number of complaints and based on other confirmed complaints of the same nature, 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.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: ALLERGAN 21GA WINGED INF SET
• Common Device Name: TISSUE EXPANDER AND ACCESSORIES
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 824 12th avenue; bethlehem PA 18018
• Manufacturer (Section G): B. BRAUN MEDICAL INC.; 824 12th avenue; bethlehem PA 18018
• Manufacturer Contact: elena reifenstein ; 901 marcon blvd; allentown, PA 18109 ; 8334251464
• MDR Report Key: 24066524
• Report Number: 2521402-2025-01681
• Device Sequence Number: 13358584
• Product Code: LCJ
• UDI-Device Identifier: 04046964787102
• UDI-Public: (01)04046964787102
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K853014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2025

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: 7M2802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 02/23/2026
• 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