MAUDE Adverse Event Report: B. BRAUN MEDICAL INC.; TISSUE EXPANDER AND ACCESSORIES

Catalog Number	7M2802
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
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 te fill needles broke off when using with allergan fill kit.Did not break on the hub but at the body of the needle.Needle was inside the patient.No patient injury was reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Seventy-two (72) unused samples in original packaging were returned for evaluation.Based on other confirmed complaints of the same nature, the reported defect is confirmed.A supplier corrective action request (scar) was issued, and the supplier conducted their investigation.The root cause for the dull needle complaints was identified as a supplier misinterpretation of the bevel angle specification, resulting in needles manufactured with an incorrect, thinner bevel more susceptible to damage during normal handling steps.Corrective actions were implemented to prevent future bevel damage and ensure the supplier adheres to the specified requirements.We will maintain this report for further references and continue to monitor other reports for similar occurrences.

• Common Device Name: TISSUE EXPANDER AND ACCESSORIES
• 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 ; 901 marcon blvd; allentown, PA 18109 ; 8334251464
• MDR Report Key: 23979833
• Report Number: 2521402-2025-01610
• Device Sequence Number: 10606051
• Product Code: LCJ
• UDI-Device Identifier: 04046964787102
• UDI-Public: (01)04046964787102(11)250822(17)320731(10)0062006454
• Combination Product (Y/N): N
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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: 7M2802
• Device Lot Number: 0062006454
• 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: 08/22/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2025
• 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