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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE
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BECTON DICKINSON UNSPECIFIED BD¿ PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE Back to Search Results
Catalog Number UNKNOWN
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/12/2024
Event Type  malfunction  
Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and/or 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 unspecified bd¿ pen needle was unable to deliver medication.The following information was provided by the initial reporter, translated from portuguese to english: the person responsible got in touch and said that he had bought 8 ampoules and had already tested 3 of them, but the medication wasn't coming out.He didn't know if the problem was with the ampoule or the pen.All 3 are from the same batch.The needle part of the ampoule is remaining.This problem started a week ago.One of the ampoules was started, but then there was a problem.Patient has been taking the treatment for a year and a half.It wasn't clear whether the problem was with the ampoule or the pen.
 
Event Description
It was reported that the unspecified bd¿ pen needle was unable to deliver medication.The following information was provided by the initial reporter, translated from portuguese to english: the person responsible got in touch and said that he had bought 8 ampoules and had already tested 3 of them, but the medication wasn't coming out.He didn't know if the problem was with the ampoule or the pen.All 3 are from the same batch.The needle part of the ampoule is remaining.This problem started a week ago.One of the ampoules was started, but then there was a problem.Patient has been taking the treatment for a year and a half.It wasn't clear whether the problem was with the ampoule or the pen.
 
Manufacturer Narrative
H.6.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no capa/sa is required at this time.
 
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Brand Name
UNSPECIFIED BD¿ 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 Key18960607
MDR Text Key339119418
Report Number2243072-2024-00431
Device Sequence Number1
Product Code FMI
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/01/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/01/2024
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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