MAUDE Adverse Event Report: B BRAUN MELSUNGEN AG NORM-JECT®; SYRINGE, PISTON

Catalog Number	NJ-4606755BMS
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
According to the event description: after reconstituting the vial a "blue floating thing" was noted in the vial."i think probably a piece of the syringe because there is blue printing on the syringe that comes with the vial" the particle observed/exhibited an elongated strip or uneven ribbon-shape exhibiting a blue coloration.An uneven yet relatively smooth surface texture was observed.The particle exhibits a negative reaction to a magnet and a non-buoyant behavior.The particle observed was not visually consistent with the stopper material.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).A follow-up report will be provided after the examination results are available.

• Brand Name: NORM-JECT®
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): B BRAUN MELSUNGEN AG; carl-braun sty. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B BRAUN MELSUNGEN AG; carl-braun sty. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer Contact: elena reifenstein ; 824 12th avenue; bethlehem, PA 18018 ; 8334251464
• MDR Report Key: 25124148
• Report Number: 9610825-2026-00248
• Device Sequence Number: 16134702
• Product Code: FMF
• UDI-Device Identifier: 04046955635825
• UDI-Public: (01)04046955635825(11)220829(17)270801(10)22H29C8
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K063280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

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 Expiration Date: 08/29/2022
• Device Catalogue Number: NJ-4606755BMS
• Device Lot Number: 22H29C8
• 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: 03/24/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/08/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2022
• 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