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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 Complete Blockage (1094)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/08/2022
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 drug solution did not come out of 3 of the bd micro-fine¿+ pro pen needle.The following information was provided by the initial reporter, translated from japanese to english: according to the patient's report, the drug solution did not come out for several products.
 
Manufacturer Narrative
H6: investigation summary: three sealed 32g x 4 mm pen needle samples and two photos were returned from lot.No.2082863, cat.No.320559.A clog test and a functionality test was carried out on all three samples and no issues were observed.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.No issues were observed with the returned samples therefore no root cause can be identified.
 
Event Description
It was reported that drug solution did not come out of 3 of the bd micro-fine¿+ pro pen needle.The following information was provided by the initial reporter, translated from japanese to english: according to the patient's report, the drug solution did not come out for several products.
 
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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 Key16057081
MDR Text Key308479919
Report Number9616656-2022-01416
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
Date FDA Received12/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number320559
Device Lot Number2082863
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/24/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/23/2022
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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