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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD ULTRA-FINE¿ SHORT PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE
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BECTON DICKINSON AND CO. BD ULTRA-FINE¿ SHORT PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE Back to Search Results
Model Number 320109
Device Problem Misconnection (1399)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/28/2022
Event Type  malfunction  
Event Description
It was reported that an unspecified number of bd ultra-fine¿ short pen needles were not functioning.The following information was provided by the initial reporter: consumer reported that the needles will not fit onto the insulin pen.Consumer does not prime needles, consumer does not re-use.
 
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 2067702.Medical device expiration date: 31-mar-2027.Device manufacture date: 08-mar-2022.Medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.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 an unspecified number of bd ultra-fine¿ short pen needles were not functioning.The following information was provided by the initial reporter: consumer reported that the needles will not fit onto the insulin pen.Consumer does not prime needles, consumer does not re-use.
 
Manufacturer Narrative
H6: investigation summary: no samples were returned therefore the complaint could not be confirmed and the root cause is undetermined.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.
 
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Brand Name
BD ULTRA-FINE¿ SHORT 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 Key15666271
MDR Text Key307009760
Report Number9616656-2022-01140
Device Sequence Number1
Product Code FMI
UDI-Device Identifier00382903201099
UDI-Public00382903201099
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K213478
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 11/09/2022
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 Lay User/Patient
Device Model Number320109
Device Catalogue Number320109
Device Lot NumberSEE H10
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/28/2022
Initial Date FDA Received10/25/2022
Supplement Dates Manufacturer Received11/09/2022
Supplement Dates FDA Received11/29/2022
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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