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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD MICRO-FINE¿+ PRO PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE
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BECTON DICKINSON AND CO. BD MICRO-FINE¿+ PRO PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE Back to Search Results
Catalog Number 320559
Device Problem Misconnection (1399)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2022
Event Type  malfunction  
Event Description
It was reported that the bd micro-fine¿+ pro pen needle felt no resistance and could not turn the dial.The following information was provided by the initial reporter, translated from japanese to english:> upon injection, i pressed the button but felt no resistance and could not turn the dial.
 
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: unknown.Device manufacture date: unknown.
 
Event Description
It was reported that the bd micro-fine¿+ pro pen needle felt no resistance and could not turn the dial.The following information was provided by the initial reporter, translated from japanese to english:> upon injection, i pressed the button but felt no resistance and could not turn the dial.
 
Manufacturer Narrative
H6: investigation summary one open 32g x 4 mm pen needle sample and three photos were returned from an unknown lot.No., cat.No.320559.A functionality test was carried out on the returned sample and no issues were observed.No dhr review can be carried out as lot number is unknown.No issues were observed with the returned sample therefore no root cause can be identified.
 
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Brand Name
BD MICRO-FINE¿+ PRO PEN NEEDLE
Type of Device
HYPODERMIC SINGLE LUMEN NEEDLE
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 Key16126792
MDR Text Key308561202
Report Number9616656-2022-01460
Device Sequence Number1
Product Code FMI
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/24/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number320559
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/23/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/20/2022
Initial Date FDA Received01/09/2023
Supplement Dates Manufacturer Received01/24/2023
Supplement Dates FDA Received02/10/2023
Was Device Evaluated by Manufacturer? Yes
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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