J-TIP SYRINGE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-01-05 for J-TIP SYRINGE * manufactured by National Medical Products, Inc..

Event Text Entries

[2450779] The pressurized j-tip syringe broke into several pieces on activation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2401935
MDR Report Key2401935
Date Received2012-01-05
Date of Report2011-10-28
Date of Event2011-10-12
Report Date2011-10-28
Date Reported to FDA2012-01-05
Date Added to Maude2012-01-06
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameJ-TIP SYRINGE
Generic NameJ-TIP 0.25 SYRINGE
Product CodeKZE
Date Received2012-01-05
Returned To Mfg2011-10-10
Model Number*
Catalog Number*
Lot NumberNMP LOT # 1104001
ID Number*
OperatorNURSE
Device AvailabilityR
Device Sequence No1
Device Event Key0
ManufacturerNATIONAL MEDICAL PRODUCTS, INC.
Manufacturer Address57 PARKER STREET IRVINE CA 92618160 US 92618 1605


Patients

Patient NumberTreatmentOutcomeDate
10 2012-01-05

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