BD * 309572

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-11-07 for BD * 309572 manufactured by Bd & Co..

Event Text Entries

[137940] Unknown material on hub of needle base. Possible banding solvent from mfg.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1020355
MDR Report Key303839
Date Received2000-11-07
Date of Report2000-11-07
Date of Event2000-11-06
Date Added to Maude2000-11-13
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameBD
Generic Name3ML 22GX1 SYRINGE & NEEDLE
Product CodeFME
Date Received2000-11-07
Model Number*
Catalog Number309572
Lot Number0E118
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key294056
ManufacturerBD & CO.
Manufacturer Address* FRANKLIN LAKES NJ 07417 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2000-11-07

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