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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD HOME SHARPS CONTAINER; HYPODERMIC SINGLE LUMEN NEEDLE
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BECTON DICKINSON BD HOME SHARPS CONTAINER; HYPODERMIC SINGLE LUMEN NEEDLE Back to Search Results
Model Number 323487
Device Problem Difficult to Open or Close (2921)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/19/2021
Event Type  malfunction  
Manufacturer Narrative
Oem manufacture: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that the bd home sharps container experienced no lid and lid difficult to close/does not close.The following information was provided by the initial reporter: material no: 323487, batch no: 0024001.Purchased a bd home sharps container and it was missing the lid to the top.Consumer stated, when she opened the new box, lid that has the "holes" in it to drop pen needles ans syringes through was broken.
 
Manufacturer Narrative
H.6.Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.
 
Event Description
It was reported that the bd home sharps container experienced no lid and lid difficult to close/does not close.The following information was provided by the initial reporter: material no: 323487, batch no: 0024001.Purchased a bd home sharps container and it was missing the lid to the top.Consumer stated, when she opened the new box, lid that has the "holes" in it to drop pen needles ans syringes through was broken.
 
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Brand Name
BD HOME SHARPS CONTAINER
Type of Device
HYPODERMIC SINGLE LUMEN NEEDLE
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key11298929
MDR Text Key265974541
Report Number2243072-2021-00270
Device Sequence Number1
Product Code FMI
UDI-Device Identifier00382903234875
UDI-Public00382903234875
Combination Product (y/n)N
PMA/PMN Number
K943139
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 04/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number323487
Device Catalogue Number323487
Device Lot Number0024001
Was Device Available for Evaluation? No
Date Manufacturer Received04/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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