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U.S. Department of Health and Human Services

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

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B. BRAUN MELSUNGEN AG NORM-JECT SYRINGE, PISTON Back to Search Results
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.
 
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Brand NameNORM-JECT
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
B. BRAUN MELSUNGEN AG
carl-braun-str. 1
melsungen, 34212
GM 34212
Manufacturer Contact
jonathan severino
861 marcon boulevard
allentown, PA 18109
4842408332
MDR Report Key10560785
MDR Text Key207748549
Report Number9610825-2020-00218
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNJ-4606205-02
Device Catalogue NumberNJ-4606205-02
Device Lot Number20A27C8
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/11/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/27/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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