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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 Failure to Eject (4010)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/07/2022
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the bd micro-fine¿+ pro pen needle was loose, and it was difficult to detach the pen needle from the pen.The following information was provided by the initial reporter, translated from japanese to english: the outer cover was loose, and it was difficult to detach the pen needle from the pen.
 
Event Description
It was reported that the bd micro-fine¿+ pro pen needle was loose, and it was difficult to detach the pen needle from the pen.The following information was provided by the initial reporter, translated from japanese to english: the outer cover was loose, and it was difficult to detach the pen needle from the pen.
 
Manufacturer Narrative
H6: investigation summary two open 32 g x 4 mm pen needle samples and three photos were returned from lot.No.2060476, cat.No.320559.A functionality test was carried out on the returned samples as per q-sop-183-dl and a loose hub in cover was observed on one sample.No issues were observed with the remaining sample.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed as per the applicable operations and met qc specifications.This issue was caused by an interference fit between the hub and the cover.
 
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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 Key16067425
MDR Text Key308262434
Report Number9616656-2022-01428
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 01/20/2023
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 Number2060476
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/08/2022
Initial Date FDA Received12/29/2022
Supplement Dates Manufacturer Received01/20/2023
Supplement Dates FDA Received02/04/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2022
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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