MAUDE Adverse Event Report: BECTON DICKINSON BD SHARPS DISPOSAL BY MAIL; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	323488
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.The manufacturing location for this product is oem - premuim plastic solution (pps).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.The customer's address is unknown.(b)(6) usa has been used as a default.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that bd sharps disposal by mail opening was too small for the needles.The following information was provided by the initial reporter: material no: 323488 batch no: unknown.It was reported that the opening of the sharps container was too small for the safety pen needles.Verbatim: home heath aid wanted to know how to use sharps container.Stated, the safety pen needles could not fit through hole.I explained, the openings are too small and will not accommodate a safety pen needle.She will need to purchase a larger sharps container.Offered a refund.Home health aid will call back if she decides to take refund.Did not provide any additional information.Will not be sending letter, replacement or mail kit.(b)(6).
Event or Problem Description
It was reported that bd sharps disposal by mail opening was too small for the needles.The following information was provided by the initial reporter: material no: 323488, batch no: unknown.It was reported that the opening of the sharps container was too small for the safety pen needles.Verbatim: home heath aid wanted to know how to use sharps container.Stated, the safety pen needles could not fit through hole.I explained, the openings are too small and will not accommodate a safety pen needle.She will need to purchase a larger sharps container.Offered a refund.Home health aid will call back if she decides to take refund.Did not provide any additional information.Will not be sending letter, replacement or mail kit.
Additional Manufacturer Narrative
Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Unable to perform dhr check for difficult/unable to operate (openings too small) due to unknown lot number.

• Brand Name: BD SHARPS DISPOSAL BY MAIL
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11821910
• Report Number: 2243072-2021-01457
• Device Sequence Number: 14530081
• Product Code: FMI
• UDI-Device Identifier: 00382903234882
• UDI-Public: 00382903234882
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K943137
• 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): 06/16/2021

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: 323488
• Device Catalogue Number: 323488
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1