HYPODERMIC NEEDLE-PRO NEEDLE WITH PROTECTION DEVICE 4658305

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2015-06-08 for HYPODERMIC NEEDLE-PRO NEEDLE WITH PROTECTION DEVICE 4658305 manufactured by Smiths Medical Inc..

Event Text Entries

[15968495] A report was rec'd that state during an injection, the needle became detached from the syringe. No needle-stick took place. There was no pt or clinician injury reported.
Patient Sequence No: 1, Text Type: D, B5


[16353257] Manufacturer completed the entire form. Customer has not yet returned the device to the manufacturer for device evaluation. When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2183502-2015-00404
MDR Report Key4838147
Report Source01,08
Date Received2015-06-08
Date of Report2015-06-08
Report Date2015-06-08
Date Reported to FDA2015-06-08
Date Mfgr Received2015-05-18
Device Manufacturer Date2014-11-18
Date Added to Maude2015-06-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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
Manufacturer ContactMICHELE SELIGA
Manufacturer Street1265 GREY FOX RD.
Manufacturer CityST. PAUL MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone6516287604
Manufacturer G1SMITHS MEDICAL, INC.
Manufacturer Street10 BOWMAN DR
Manufacturer CityKEENE NH 03431
Manufacturer CountryUS
Manufacturer Postal Code03431
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHYPODERMIC NEEDLE-PRO NEEDLE WITH PROTECTION DEVICE
Generic NameHYPODERMIC NEEDLE
Product CodeFMJ
Date Received2015-06-08
Model NumberNA
Catalog Number4658305
Lot Number2736438
ID NumberNA
Device Expiration Date2019-11-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeNA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL INC.
Manufacturer AddressKEENE NH US


Patients

Patient NumberTreatmentOutcomeDate
10 2015-06-08

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