LEADERFLEX 22G 20CM 1212.20

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-23 for LEADERFLEX 22G 20CM 1212.20 manufactured by Vygon Gmbh.

Event Text Entries

[186731731] One failed sample and several unopened samples from the same lot have been returned to vygon and will be evaluated as part of the complaint investigation. The results of this investigation are still pending and will be communicated to fda within 30 days of completion. There were 5 occurrences of this issue, the details for the events can be found in the following reports: 2245270-2020-00013, 2245270-2020-00014, 2245270-2020-00016, 2245270-2020-00017.
Patient Sequence No: 1, Text Type: N, H10


[186731732] At least 5 20cm leaderflex catheters being used as piccs have broken at various points of usage, from insertion, during dwell, to removal. No harm to patients reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2245270-2020-00015
MDR Report Key9866533
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-03-23
Date of Report2020-03-23
Date of Event2020-02-20
Date Mfgr Received2020-03-18
Date Added to Maude2020-03-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactCLAIRE PADDOCK
Manufacturer Street2750 MORRIS ROAD
Manufacturer CityLANSDALE, PA
Manufacturer CountryUS
Manufacturer Phone4735414
Manufacturer G1VYGON GMBH
Manufacturer StreetPRAGER RING 100
Manufacturer CityAACHEN, 52070
Manufacturer CountryGM
Manufacturer Postal Code52070
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLEADERFLEX 22G 20CM
Generic NameINTRAVASCULAR CATHETER
Product CodeFOZ
Date Received2020-03-23
Returned To Mfg2020-03-18
Model Number1212.20
Catalog Number1212.20
Lot Number290519GH
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerVYGON GMBH
Manufacturer AddressPRAGER RING 100 AACHEN, 52070 GM 52070


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-23

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