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U.S. Department of Health and Human Services

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

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B. BRAUN MEDICAL INC. NORM-JECT-F LUER SOLO 1 ML (NJ-9166017-02) SYRINGE, PISTON Back to Search Results
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).
 
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Brand NameNORM-JECT-F LUER SOLO 1 ML (NJ-9166017-02)
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
MDR Report Key12407214
MDR Text Key269791965
Report NumberMW5103652
Device Sequence Number1
Product Code FMF
Reporter Country CodeUS
Number of Events Reported1
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  
0 Patients were Involved in the Event:
Date FDA Received08/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNJ-9166017-02
Device Catalogue NumberNJ-9166017-02
Device Lot Number21B11C8
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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