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

Model Number	NJ-4606205-02
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 event 2 of b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
Event or Problem Description
As reported by the user facility: event 2: fiber-like particles were identified in a finished product manufactured utilizing this syringe as an in-process component.The particles appear to be natural/cellulose textiles, either blue or blue-black in color.
Additional Manufacturer Narrative
This report has been identified as event 2 of b.Braun medical internal report number (b)(4).Several photos were provided for evaluation.Upon visual examination, it was noted that a blue colored fiber was present inside the syringe cylinder.Upon further evaluation, it was determined that this fiber likely came from clothing worn in the cleanroom.In this clean room, the employees are wearing appropriate cleanroom clothing such as a headgear and a clean room smock.Despite of the cleanroom clothing worn by the employees, it cannot be completely excluded, that in very rare cases a fiber could have come from the clothing.Since the syringe components are made of plastic, they can charge statically and attract a loose fiber relatively easily.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 will be submitted.

• Brand Name: NORM-JECT
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• MDR Report Key: 10560776
• Report Number: 9610825-2020-00219
• Device Sequence Number: 11549287
• Product Code: FMF
• UDI-Device Identifier: 04046955597093
• UDI-Public: 04046955597093
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2020

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: 01/01/2025
• Device Model Number: NJ-4606205-02
• Device Catalogue Number: NJ-4606205-02
• Device Lot Number: 20A27C8
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 10/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1