PEN NDL 32G 4MM PRO 14 BAG 700 CASE JPX 320559

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,other report with the FDA on 2020-03-20 for PEN NDL 32G 4MM PRO 14 BAG 700 CASE JPX 320559 manufactured by Becton Dickinson And Co..

Event Text Entries

[186306400] Date of event: unknown. The date received by manufacturer has been used for this field. Device expiration date: unknown. Investigation summary: no samples or photos were returned for analysis. Investigation conclusion: no dhr review can be carried out as lot number is unknown. Rationale: based on an evaluation of severity and occurrence it was determined that no corrective action is required at this time. Device manufacture date: unknown.
Patient Sequence No: 1, Text Type: N, H10


[186306401] It was reported that an unspecified number of pen ndl 32g 4mm pro 14 bag 700 case jpx experienced the cannula breaking off on the patient and non patient end. Product defects were noted during use. The following information was provided by the initial reporter: a patient changed from a competitor's product to micro fine pro. Then needle pe and npe breakage occurs often.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9616656-2020-00246
MDR Report Key9861748
Report SourceCONSUMER,FOREIGN,OTHER
Date Received2020-03-20
Date of Report2020-03-05
Date of Event2020-03-04
Date Mfgr Received2020-03-04
Date Added to Maude2020-03-20
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 ContactBDX BRETT WILKO
Manufacturer Street9450 SOUTH STATE STREET
Manufacturer CitySANDY UT 84070
Manufacturer CountryUS
Manufacturer Postal84070
Manufacturer Phone8015652341
Manufacturer G1BECTON DICKINSON AND CO.
Manufacturer StreetPOTTERY ROAD
Manufacturer CityDUN LAOGHAIRE CO
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePEN NDL 32G 4MM PRO 14 BAG 700 CASE JPX
Generic NamePEN NEEDLE
Product CodeFMI
Date Received2020-03-20
Catalog Number320559
Lot NumberUNKNOWN
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBECTON DICKINSON AND CO.
Manufacturer AddressPOTTERY ROAD DUN LAOGHAIRE CO


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-20

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