HUBER NEEDLE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-11 for HUBER NEEDLE manufactured by B. Braun Medical.

Event Text Entries

[105153747]
Patient Sequence No: 1, Text Type: N, H10


[105153748] Needle bent during port access. Manufacturer response for huber needle, (brand not provided) (per site reporter) : none yet.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number7420969
MDR Report Key7420969
Date Received2018-04-11
Date of Report2018-04-06
Date of Event2017-08-21
Report Date2018-04-06
Date Reported to FDA2018-04-06
Date Reported to Mfgr2018-04-06
Date Added to Maude2018-04-11
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Generic NameHUBER NEEDLE
Product CodePTI
Date Received2018-04-11
OperatorNURSE
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerB. BRAUN MEDICAL
Manufacturer Address901 MARCON BLVD. ALLENTOWN PA 18109 US 18109


Patients

Patient NumberTreatmentOutcomeDate
10 2018-04-11

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