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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD ULTRA-FINE¿ PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE
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BECTON DICKINSON BD ULTRA-FINE¿ PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE Back to Search Results
Catalog Number 329705
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/20/2023
Event Type  malfunction  
Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.H.3.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 ultra-fine¿ pen needle was unable to attach.Report 2 of 2.The following was translated from japanese to english: customer reported that unable to attach needle due to npe of the needle breakage.
 
Manufacturer Narrative
H.6.Investigation summary: samples were received and an investigation was performed.Embecta was not able to duplicate or confirm the indicated issue.Complaints received for this device and reported condition will continue to be tracked and trended.Based on the above, no additional investigation and correctivepreventative action (capa) or situational analysis (sa) is required.
 
Event Description
It was reported that the bd ultra-fine¿ pen needle was unable to attach.Report 2 of 2.The following was translated from japanese to english: customer reported that unable to attach needle due to npe of the needle breakage.
 
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Brand Name
BD ULTRA-FINE¿ PEN NEEDLE
Type of Device
HYPODERMIC SINGLE LUMEN NEEDLE
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
jennifer suh
5859 farinon drive
san antonio, TX 78249
8448235433
MDR Report Key18357899
MDR Text Key331194439
Report Number2243072-2023-02211
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 02/01/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number329705
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/01/2024
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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