MAUDE Adverse Event Report: NORM-JECT®; SYRINGE, PISTON

Model Number	NJ-4606108-02
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).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 the user facility: during the packaging process at pci (packaging coordinators inc.), an unknown substance was discovered inside of the packaging and on the syringe plunger.Notification of non-conforming material was reported to boston scientific, (b)(4).
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).One (1) 10 ml norm-ject bbraun air-tite sample in open packaging and a picture were received for evaluation.Visual examination of the sample showed a black/brown particles (burned material) inside the material of the piston rod.The cause of the inclusions is the injection molding process.Cavity 49 was the affected cavity of the molding tool kz103.The set material in the molding tool or machine is the root cause of the inclusion.The error pattern could occur due to too large shear force in the machine or the tool, after a production break.At the subsequent starting procedure, the material reached into the cavity.A complete prevention of this issue is not possible in the molding process.Because the particles are embedded in the material, there is no hazard for users, patients or third parties.It is an optical defect.The batch record was reviewed and no deviations were noted.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: NORM-JECT®
• Common Device Name: SYRINGE, PISTON
• MDR Report Key: 12488723
• Report Number: 9610825-2021-00382
• Device Sequence Number: 3602734
• Product Code: FMF
• UDI-Device Identifier: 04046955597031
• UDI-Public: (01)04046955597031
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2021

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-4606108-02
• Device Catalogue Number: NJ-4606108-02
• Device Lot Number: 21A18C8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Initial Date Received by Manufacturer: 09/02/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 09/17/2021
• Supplement Report FDA Received Date: 10/29/2021
• 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