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

Model Number NJ-4606205-02

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as event 1 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 Description

As reported by the user facility: event 1: 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.

Manufacturer Narrative

This report has been identified as event 1 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
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• MDR Report Key: 10560785
• MDR Text Key: 207748549
• Report Number: 9610825-2020-00218
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 04046955597093
• UDI-Public: 04046955597093
• Combination Product (y/n): N
• PMA/PMN Number: K063280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NJ-4606205-02
• Device Catalogue Number: NJ-4606205-02
• Device Lot Number: 20A27C8
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1