MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG NORM-JECT®; Syringe, Piston

Catalog Number	NJ-4606701-02
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction

• Brand Name: NORM-JECT®
• Common Device Name: Syringe, Piston
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str.1; melsungen, hesse 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str.1; melsungen, hesse 34212 ; GM 34212
• Manufacturer Contact: elena reifenstein ; 824 12th avenue; bethlehem,, PA 18018
• MDR Report Key: 50822368
• Report Number: 9610825-2026-00519
• Device Sequence Number: 10218812
• Product Code: FMF
• UDI-Device Identifier: 04046955597123
• UDI-Public: (01)04046955597123(11)250616(17)300601(10)25F16C8
• 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
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: 06/01/2026
• Device Catalogue Number: NJ-4606701-02
• Device Lot Number: 25F16C8
• 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: 08/25/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2025
• 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