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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE; PISTON SYRINGE
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BECTON DICKINSON AND CO. BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE; PISTON SYRINGE Back to Search Results
Catalog Number 320424
Device Problem Failure to Deliver (2338)
Patient Problem Insufficient Information (4580)
Event Date 01/20/2022
Event Type  malfunction  
Manufacturer Narrative
Device expiration date: unknown initial reporter first name: the initial reporter is known on twitter as (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
 
Event Description
It was reported that 12-15 bd insulin syringes with bd ultra-fine¿ needles were not functioning.The following information was provided by the initial reporter: just lately my bd viva pen needles 0,25mm 31g 5mm have a failure rate of between 12-15 needles per 90 pack.
 
Manufacturer Narrative
Device expiration date: unknown initial reporter first name: the initial reporter is known on (b)(6) as (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
 
Event Description
It was reported that 12-15 bd insulin syringes with bd ultra-fine¿ needles were not functioning.The following information was provided by the initial reporter: just lately my bd viva pen needles 0,25mm 31g 5mm have a failure rate of between 12-15 needles per 90 pack.
 
Manufacturer Narrative
H6: investigation summary no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A device history review could not be completed as no batch number was provided.H3 other text : see h10.
 
Event Description
It was reported that 12-15 bd insulin syringes with bd ultra-fine¿ needles were not functioning.The following information was provided by the initial reporter: just lately my bd viva pen needles 0,25mm 31g 5mm have a failure rate of between 12-15 needles per 90 pack.
 
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Brand Name
BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON AND CO.
pottery road
dun laoghaire co
Manufacturer (Section G)
BECTON DICKINSON AND CO.
pottery road
dun laoghaire co
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13446984
MDR Text Key285165564
Report Number9616656-2022-00101
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Consumer
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number320424
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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