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).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: after filling.1cc liquid into two a1 syringes, inspection revealed two monofilament foreign particles within both of the a1 syringes.On august 23, 2021, it was reported by customer compound preferred that the source of the blue monofilament objects originated from the a1 syringes.A photograph of an unopened a1 syringe reveals a similar strand within the sterile packaged 1cc syringe.
Event or Problem Description
As reported by the user facility: event 1: after filling.1cc liquid into two a1 syringes, inspection revealed two monofilament foreign particles within both of the a1 syringes.On august 23, 2021, it was reported by customer compound preferred that the source of the blue monofilament objects originated from the a1 syringes.A photograph of an unopened a1 syringe reveals a similar strand within the sterile packaged 1cc syringe.Correction: customer originally reported two (2) occurrences (one occurrence each with 2 batch numbers, b.Braun reference numbers (b)(4)), however further information was received that there were fourteen (14) occurrences with batch 21b11c8 but fifteen (15) samples were received.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4), event 1.The investigation into this reported event is ongoing.A follow-up report will be submitted when the results of the investigation are available.

• Brand Name: NORM-JECT
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl- braun strabe 1; melsungen, 34212 ; GM 34212
• MDR Report Key: 12439857
• Report Number: 9610825-2021-00355
• Device Sequence Number: 3779462
• 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): 09/14/2021

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-9166017-02
• Device Catalogue Number: NJ-9166017-02
• Device Lot Number: 21B11C8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1