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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-4606108-02
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 b. Braun medical inc. Internal report number (b)(4). The investigation into this reported event is ongoing. A follow-up report will be submitted when the results of the investigation are available.
 
Event Description
As reported by the user facility: during the packaging process at pci (packaging coordinators inc. ), an unknown substance was discovered inside of the packaging and on the syringe plunger. Notification of non-conforming material was reported to boston scientific, (b)(4).
 
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Brand NameNORM-JECT
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
B. BRAUN MELSUNGEN AG
carl- braun strabe 1
melsungen, 34212
GM 34212
Manufacturer (Section G)
B. BRAUN MELSUNGEN AG
carl- braun strabe 1
melsungen, 34212
GM 34212
Manufacturer Contact
jonathan severino
861 marcon blvd.
allentown, PA 18109
4847197287
MDR Report Key12488723
MDR Text Key271926581
Report Number9610825-2021-00382
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 health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNJ-4606108-02
Device Catalogue NumberNJ-4606108-02
Device Lot Number21A18C8
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/13/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/02/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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