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

Model Number	NJ-9166017-02
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4), event 6.The investigation into this reported event is ongoing.A follow-up report will be submitted when the results of the investigation are available.
Event or Problem Description
As reported by user facility: event 6.Customer reported the presence of unidentified particulates in several of the syringes.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).Multiple sample were returned for investigation.The received samples were checked according to test method 102000 "contamination".Upon investigation of the samples-no particles could be detected according to test specification.Further analysis of the samples was performed with the help of a microscope.The very small particles were unable to be identified.Because the complained particles cannot be detected with specified test method, the received samples are within the specifications.The complaint is classified as not confirmed.The cause of the small blue particles is the assembling process.During the process, plungers are guided in the machine with the help of a blue conveyor.Because the conveyor showed abrasion, we assume that the particles are out of this abrasion and was attracted by electrostatic charge of the plungers.Due to this report and other reports of this nature, the manufacturer has initiated a corrective action and preventive action (capa 228967 in order to further address issues with particulate contamination.

• Brand Name: NORM-JECT®
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl- braun strabe 1; melsungen, 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl- braun strabe 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 12474665
• Report Number: 9610825-2021-00379
• Device Sequence Number: 3779690
• Product Code: FMF
• UDI-Device Identifier: 04046955596911
• UDI-Public: (01)04046955596911
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2023

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 Model Number: NJ-9166017-02
• Device Catalogue Number: NJ-9166017-02
• Device Lot Number: 21D26C8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (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