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

Model Number	NJ-9166017-02
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
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 user facility: graduation lines were misaligned.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).Thirteen (13) unused samples were received for evaluation.All thirteen (13) samples were tested and found to be within specification.Review of the device history record performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: NORM-JECT
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• MDR Report Key: 11778684
• Report Number: 9610825-2021-00156
• Device Sequence Number: 19744587
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2021

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 Expiration Date: 01/01/2026
• Device Model Number: NJ-9166017-02
• Device Catalogue Number: NJ-9166017-02
• Device Lot Number: 21A04C8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1