MAUDE Adverse Event Report: BECTON DICKINSON BD HOME SHARPS CONTAINER; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	323487
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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.

• Brand Name: BD HOME SHARPS CONTAINER
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11298929
• Report Number: 2243072-2021-00270
• Device Sequence Number: 12001841
• Product Code: FMI
• UDI-Device Identifier: 00382903234875
• UDI-Public: 00382903234875
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K943139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: 323487
• Device Catalogue Number: 323487
• Device Lot Number: 0024001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 02/08/2021
• Supplement Report FDA Received Date: 05/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1