MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. NORM-JECT-F LUER SOLO 1 ML (NJ-9166017-02); SYRINGE, PISTON

Model Number NJ-9166017-02

Device Problems Contamination (1120); Particulates (1451)

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

Event Date 08/04/2021

Event Type  malfunction  

Event Description

We are a 503b outsourcing facility.After repackaging of an avastin lot, we observed two blue particles within finished product syringes.A long investigation ensued and we were able to determine the lot of syringes have particles in it from the manufacturer.We had to reject the lot of avastin we made due to this.We placed the lot of syringes on qa hold and ordered a new lot.The new lot also contains particles.The particles are only visible under magnification; therefore, we inspected sealed syringes under 15x magnification before making another lot (which was also sent for subvisible particle testing), but feel as through these syringes are entirely unsafe to continue to be used for any type of injection.We have ceased further production using these syringes, which accounts for over 60% of our business.We reached out to the manufacturer (air-tite / b.Braun) and they have started a complaint/investigation as well (reference #(b)(4)).We have inspected unused and sealed syringes from three (3) separate lots, and all have been found to have varying levels of particles.Item description norm-ject-f luer solo 1 ml (nj-9166017-02) lot # dom, exp qty inspected, qty with fod 21b11c8, 2021-02-11, 2026-02-01, 222 14 20m23c8; 2020-11-23, 2025-11-01, 200 3 21d26c8, 2021-04-26, 2026-04-01 100, 8.Inspection at 15x magnification recorded in section, "tell us what happened and how it happened." air-tite and b.Braun; device only problem, no patient impact at this point.Fda safety report id# (b)(4).

• Brand Name: NORM-JECT-F LUER SOLO 1 ML (NJ-9166017-02)
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 12407214
• MDR Text Key: 269791965
• Report Number: MW5103652
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 04046955596911
• UDI-Public: (01)04046955596911
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 08/30/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: NJ-9166017-02
• Device Catalogue Number: NJ-9166017-02
• Device Lot Number: 21B11C8
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 1 DA