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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG Spinocan®; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

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B. BRAUN MELSUNGEN AG Spinocan®; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) Back to Search Results
Catalog Number 333320
Medical Device Problem Code Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event Malfunction
Event or Problem Description
This report has been identified as b.Braun medical internal number (b)(4).As reported by the user facility: it was reported that the needles have a green substance on the hub.No injury reported.
 
 
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Brand Name
Spinocan®
Common Device Name
NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
Manufacturer (Section D)
B. BRAUN MELSUNGEN AG
carl-braun-str.1
melsungen, 34212
GM  34212
MDR Report Key50928058
Report Number50928058
Device Sequence Number10734712
Product Code BSP
UDI-Device Identifier04046964833236
UDI-Public(01)04046964833236(11)260511(17)310430(10)0062070929
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Voluntary
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 10/02/2026
Report Date (Section F) 09/29/2026
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 Catalogue Number333320
Device Lot Number0062070929
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer09/10/2026
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date09/03/2026
Device Age4 MO
Event Location Hospital
Date Report to Manufacturer09/03/2026
Initial Date Received by Manufacturer Not provided
Supplement Date Received by ManufacturerNot provided
Initial Report FDA Received Date09/29/2026
Supplement Report FDA Received Date10/02/2026
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)
No
Patient Sequence Number1
Patient SexUnknown
Date Report Sent to FDA09/29/2026
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