PN 32X4 EUROPE BD 320211

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other,use report with the FDA on 2020-03-20 for PN 32X4 EUROPE BD 320211 manufactured by Becton Dickinson And Co..

Event Text Entries

[186306159] Device expiration date: unknown. (b)(6). Device manufacture 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.
Patient Sequence No: 1, Text Type: N, H10


[186306160] It was reported that an unspecified number of pn 32x4 europe bd were unable or difficult to prime prior to use. The following information was provided by the initial reporter: product: bd pen needletm 4mm, 320211. Complaint: the customer contacted distributor for medical device supplies. Customer told that in box many of the needles were clogged/insulin did not flow.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9616656-2020-00250
MDR Report Key9862320
Report SourceDISTRIBUTOR,FOREIGN,OTHER,USE
Date Received2020-03-20
Date of Report2020-03-09
Date of Event2019-09-09
Date Mfgr Received2020-03-06
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 NamePN 32X4 EUROPE BD
Generic NamePEN NEEDLE
Product CodeFMI
Date Received2020-03-20
Catalog Number320211
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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