HYPODERMIC NEEDLE-PRO WITH NEEDLE PROTECTION DEVICE UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-04-22 for HYPODERMIC NEEDLE-PRO WITH NEEDLE PROTECTION DEVICE UNK manufactured by Smiths Medical Inc.

Event Text Entries

[5773071] A report was received that stated during an injection, the needle became detached from the syringe. The nurse removed the needle from the patient manually. No needle-stick took place. There was no patient or clinician injury reported.
Patient Sequence No: 1, Text Type: D, B5


[13323079] Customer has not yet returned the device to the manufacturer for device evaluation. When and if the device becomes available and its 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 Number2183502-2015-00269
MDR Report Key4734808
Report Source08
Date Received2015-04-22
Date of Report2015-04-21
Report Date2015-04-21
Date Reported to FDA2015-04-21
Date Mfgr Received2015-04-02
Date Added to Maude2015-06-08
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 SALIGA
Manufacturer Street1265 GREY FOX RD.
Manufacturer CityST. PAUL MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone6516287604
Manufacturer G1SMITHS MEDICAL INC
Manufacturer Street10 BOWMAN DRIVE
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 WITH NEEDLE PROTECTION DEVICE
Generic NameFMJ-NEEDLE, HYPODERMIC
Product CodeFMJ
Date Received2015-04-22
Model NumberNA
Catalog NumberUNK
Lot NumberUNK
ID NumberNA
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 2015-04-22

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