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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD MICRO-FINE¿+ PEN NEEDLES 32G X 4MM; HYPODERMIC SINGLE LUMEN NEEDLE
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BECTON DICKINSON AND CO. BD MICRO-FINE¿+ PEN NEEDLES 32G X 4MM; HYPODERMIC SINGLE LUMEN NEEDLE Back to Search Results
Catalog Number 320136
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/24/2023
Event Type  malfunction  
Manufacturer Narrative
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 prior to use with bd micro-fine¿+ pen needles 32g x 4mm the outer cover was discovered to be loose.The following information was provided by the initial reporter, translated from japanese to english: the user reported about a loose outer cover.
 
Manufacturer Narrative
H6: investigation summary: one open 32g x 4mm pen needle and two photos were returned from lot.No.2284595, cat.No.320136.A functionality test was carried out on the returned sample 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 prior to use with bd micro-fine¿+ pen needles 32g x 4mm the outer cover was discovered to be loose.The following information was provided by the initial reporter, translated from japanese to english: the user reported about a loose outer cover.
 
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Brand Name
BD MICRO-FINE¿+ PEN NEEDLES 32G X 4MM
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
8448235433
MDR Report Key17167490
MDR Text Key318031939
Report Number9616656-2023-00607
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 07/13/2023
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 Number320136
Device Lot Number2284595
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/13/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/24/2023
Initial Date FDA Received06/20/2023
Supplement Dates Manufacturer Received07/13/2023
Supplement Dates FDA Received08/01/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/11/2022
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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