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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-9166017-02
Medical Device Problem Code Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4), event 7.The investigation into this reported event is ongoing.A follow-up report will be submitted when the results of the investigation are available.
 
Event or Problem Description
As reported by user facility: event 7.Customer reported the presence of unidentified particulates in several of the syringes.
 
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Brand Name
NORM-JECT
Common Device Name
SYRINGE, PISTON
Manufacturer (Section D)
B. BRAUN MELSUNGEN AG
carl- braun strabe 1
melsungen, 34212
GM  34212
MDR Report Key12474674
Report Number9610825-2021-00380
Device Sequence Number3779691
Product Code FMF
UDI-Device Identifier04046955596911
UDI-Public(01)04046955596911
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
PMA/510(K) Number
K063280
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 09/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberNJ-9166017-02
Device Catalogue NumberNJ-9166017-02
Device Lot Number21D26C8
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/02/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/25/2021
Initial Report FDA Received Date09/15/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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