MAUDE Adverse Event Report: BECTON DICKINSON BD¿ HOME SHARPS CONTAINER, 1.4 QUART; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	323487
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location for this product is premuim plastic solution (pps).This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1., and the franklin lakes fda registration number has been used for the manufacture report number.B.3.Date of event is unknown; awareness date has been used for this field.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd¿ home sharps container, 1.4 quart the sharps pierced the wall.There was no report of patient impact.The following information was provided by the initial reporter: consumer reported caller thought he could insert a eppe pen into the sharps container.Plus remove the needle from the eppe pen according to the directions on the box as he read it.
Event or Problem Description
It was reported while using bd¿ home sharps container, 1.4 quart the sharps pierced the wall.There was no report of patient impact.The following information was provided by the initial reporter: consumer reported caller thought he could insert a eppe pen into the sharps container.Plus remove the needle from the eppe pen according to the directions on the box as he read it.
Additional Manufacturer Narrative
H6: investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no capa/sa is required at this time.

• Brand Name: BD¿ HOME SHARPS CONTAINER, 1.4 QUART
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17909498
• Report Number: 2243072-2023-01821
• Device Sequence Number: 18023894
• Product Code: FMI
• UDI-Device Identifier: 10885403960109
• UDI-Public: (01)10885403960109
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K072105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2023

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
• Operator of Device: Other
• Device Catalogue Number: 323487
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2023
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown